KETOSTIX® 2881
GUDID 40301932881216
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
Urine ketone IVD, kit, colorimetric dipstick, rapid| 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
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 |
| 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 |
| 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 |
| 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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