CONTOUR® NEXT 85723154
GUDID 40301937277359
Blood Glucose Test strips. 35 test strips.
ASCENSIA DIABETES CARE US INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 40301937277359 |
| NIH Device Record Key | 801f2049-2bf3-4619-9210-818495d07214 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONTOUR® NEXT |
| Version Model Number | 7277 |
| Catalog Number | 85723154 |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US INC. |
| Device Count | 35 |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 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 immediately and tightly after removing a test strip. Do not use after expiration date. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301937277016 [Unit of Use] |
| GS1 | 00301937277351 [Package] Contains: 10301937277358 Package: carton [1 Units] In Commercial Distribution |
| GS1 | 10301937277358 [Primary] |
| GS1 | 40301937277359 [Package] Contains: 00301937277351 Package: case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121190
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 | 2024-11-07 |
| Device Publish Date | 2017-11-03 |
On-Brand Devices [CONTOUR® NEXT]
| 40301939697018 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabete |
| 40301937379015 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl |
| 40301937377011 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl |
| 40301937283350 | Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 1030193731025 |
| 10301937313100 | Blood Glucose Test Strips - 10 Test Strips. |
| 40301939737219 | Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 tes |
| 40301939736502 | Blood Glucose Test Strips - 50 Test Strips. |
| 40301939735253 | Blood Glucose Test Strips - 25 Test Strips. |
| 40301937357501 | Blood Glucose Test Strips - 50 Test Strips. |
| 40301937308503 | Blood Glucose Test Strips - 50 Test Strips. |
| 50301937315010 | Control Solution - Level 1. 1 x 2.5 mL. |
| 50301937314013 | Control Solution - Level 2. 1 x 2.5 mL. |
| 40301937278707 | Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test |
| 40301937277359 | Blood Glucose Test strips. 35 test strips. |
Trademark Results [CONTOUR]
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