InSure® ONE™
GUDID 30850093003317
InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01)
ENTERIX INC.
Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Home faecal specimen collection kit IVD Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use Faecal specimen collection kit IVD, home-use| Primary Device ID | 30850093003317 |
| NIH Device Record Key | 7c369247-d45a-4ba2-880e-d021c15d4ddc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InSure® ONE™ |
| Version Model Number | 01 |
| Company DUNS | 002224009 |
| Company Name | ENTERIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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| Phone | 18005313681 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Heat and Direct Sun Light |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850093003316 [Primary] |
| GS1 | 10850093003313 [Package] Contains: 00850093003316 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 20850093003310 [Package] Contains: 00850093003316 Package: Case [25 Units] In Commercial Distribution |
| GS1 | 30850093003317 [Package] Contains: 00850093003316 Package: Case [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170548
FDA Product Code
| KHE | Reagent, Occult Blood |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-05 |
On-Brand Devices [InSure® ONE™]
| 00850093003354 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit |
| 00850093003347 | InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bu |
| 30850093003317 | InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01 |
| 00850093003309 | InSure® ONE™ Sample Kit - NOT FOR SALE Contains 2 Collection Kits, 2 individually-pouched Tes |
| 00850093003293 | InSure® ONE™ Run Buffer - 1 Liter Bottle |
| 00850093003286 | InSure® ONE™ Test Cards for QC - 50 pack |
| 00850093003279 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit |
| 00850093003231 | InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run |
Trademark Results [InSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSURE 98041149 not registered Live/Pending |
Curtiss-Wright Flow Control Corporation 2023-06-13 |
 INSURE 86901380 5044834 Live/Registered |
Enterix, Inc. 2016-02-08 |
 INSURE 78232524 2909232 Dead/Cancelled |
Enterix Inc. 2003-04-01 |
 INSURE 78232512 2978654 Live/Registered |
Enterix Inc. 2003-04-01 |
 INSURE 78165733 2732347 Live/Registered |
Brandt Consolidated, Inc. 2002-09-19 |
 INSURE 77920655 not registered Dead/Abandoned |
WARBINGTON, TIMOTHY 2010-01-26 |
 INSURE 77726007 4364957 Live/Registered |
Geovada LLC 2009-04-30 |
 INSURE 77118666 not registered Dead/Abandoned |
W.C. Bradley Company 2007-02-28 |
 INSURE 77118438 not registered Indifferent |
W.C. Bradley Company 0000-00-00 |
 INSURE 76533458 not registered Dead/Abandoned |
Botanical Laboratories, Inc. 2003-07-30 |
 INSURE 76494198 not registered Dead/Abandoned |
Mannington Carpets, Inc. 2003-03-03 |
 INSURE 76024894 2675417 Dead/Cancelled |
SCHWAN'S IP, LLC 2000-04-13 |
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