KETOSTIX® 2881
GUDID 40301932881216
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
Urine ketone IVD, kit, colorimetric dipstick, rapid Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical Urine ketone IVD, kit, rapid colorimetric, clinical| Primary Device ID | 40301932881216 |
| NIH Device Record Key | bb73ba44-c08c-4ee2-88a4-0c77ee15f9b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KETOSTIX® |
| Version Model Number | 2881 |
| Catalog Number | 2881 |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US INC. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com | |
| Phone | 800-348-8100 |
| support@contournext.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal. |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301932881010 [Unit of Use] |
| GS1 | 00301932881218 [Package] Contains: 10301932881215 Package: carton [1 Units] In Commercial Distribution |
| NDC/NHRIC | 0193-2880-21 [Secondary] |
| GS1 | 10301932881215 [Primary] |
| GS1 | 40301932881216 [Package] Contains: 00301932881218 Package: shipper/case [12 Units] In Commercial Distribution |
FDA Product Code
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-21 |
| Device Publish Date | 2019-06-06 |
On-Brand Devices [KETOSTIX®]
| 40301932881216 | Reagent Strips for Urinalysis: Ketone |
| 40301932880509 | Reagent Strips for Urinalysis: Ketone |
Trademark Results [KETOSTIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KETOSTIX 88151678 not registered Live/Pending |
Ascensia Diabetes Care Holdings AG 2018-10-11 |
 KETOSTIX 72021108 0656284 Live/Registered |
AMES COMPANY, INC. 1956-12-17 |
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