CONTOUR® 7080G
GUDID 40301939727210
Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - NDC # 0193-7090-21).
ASCENSIA DIABETES CARE US INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 40301939727210 |
| NIH Device Record Key | 806f9ad7-8f79-4fef-8a6a-1023a14a3476 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONTOUR® |
| Version Model Number | 7080G |
| Catalog Number | 7080G |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US INC. |
| Device Count | 50 |
| 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 | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301937080012 [Unit of Use] |
| GS1 | 00301937080500 [Package] Contains: 10301937080507 Package: carton [1 Units] In Commercial Distribution |
| GS1 | 00301937090219 [Package] Contains: 10301937080507 Package: carton [2 Units] In Commercial Distribution |
| NDC/NHRIC | 0193-7080-50 [Secondary] |
| GS1 | 10301937080507 [Primary] |
| GS1 | 40301937080508 [Package] Contains: 00301937080500 Package: shipper/case [24 Units] In Commercial Distribution |
| GS1 | 40301937090217 [Package] Contains: 00301937090219 Package: shipper/case [12 Units] In Commercial Distribution |
| GS1 | 40301939602043 [Package] Contains: 00301937080500 Package: shipper / speed pack [4 Units] In Commercial Distribution |
| GS1 | 40301939603040 [Package] Contains: 00301937090219 Package: shipper / speed pack [4 Units] In Commercial Distribution |
| GS1 | 40301939726503 [Package] Contains: 00301937080500 Package: shipper/case [24 Units] Discontinued: 2017-07-31 Not in Commercial Distribution |
| GS1 | 40301939727210 [Package] Contains: 00301937090219 Package: shipper/case [12 Units] Discontinued: 2017-07-31 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062058
FDA Product Code
| LFR | Glucose Dehydrogenase, Glucose |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-02 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [CONTOUR®]
| 40301939556018 | Blood Glucose Monitoring System. For self-testing, monitoring and management of blood glucose. C |
| 40301939545012 | Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In |
| 40301937189010 | Blood Glucose Monitoring System. For self-monitoring and management of blood glucose. Contents: |
| 40301937151017 | Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. T |
| 40301939727210 | Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-70 |
| 40301939725254 | Blood Glucose Test strips. 25 test strips. |
| 40301939507102 | Blood Glucose Test strips. 10 test strips. |
| 50301937111018 | Control Solution - High, 1 x 2.5 mL |
| 50301937110011 | Control Solution - Low, 1 x 2.5 mL |
| 00301937109010 | Control Solution - Normal, 1 x 2.5 mL |
| 40301937099500 | Blood Glucose Test strips. 50 test strips. |
| 40301937098503 | Blood Glucose Test strips. 50 test strips. |
| 40301937097506 | Blood Glucose Test strips. 50 test strips. |
Trademark Results [CONTOUR]
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