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| 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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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 98747775 not registered Live/Pending |
Creative Empowering Solutions, LLC 2024-09-12 |
 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 |
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