CONTOUR® NEXT EZ and CONTOUR® NEXT 5534
GUDID 40301935534515
Mixed product shipper case containing 6 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502).
ASCENSIA DIABETES CARE US INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 40301935534515 |
| NIH Device Record Key | 484b12ff-11bd-46e7-99eb-de6b25cbf71c |
| Commercial Distribution Discontinuation | 2018-06-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CONTOUR® NEXT EZ and CONTOUR® NEXT |
| Version Model Number | 5534 |
| Catalog Number | 5534 |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com | |
| Phone | 1-800-348-8100 |
| support@contournext.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 40301935534515 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111268
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 | 2019-06-07 |
| Device Publish Date | 2016-12-16 |
Devices Manufactured by ASCENSIA DIABETES CARE US INC.
| 40301937277359 - CONTOUR® NEXT | 2024-11-07 Blood Glucose Test strips. 35 test strips. |
| 40301937278707 - CONTOUR® NEXT | 2024-11-07 Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total). |
| 40301937097506 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
| 40301937098503 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
| 40301937099500 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
| 00301937109010 - CONTOUR® | 2024-11-06 Control Solution - Normal, 1 x 2.5 mL |
| 50301937110011 - CONTOUR® | 2024-11-06 Control Solution - Low, 1 x 2.5 mL |
| 50301937111018 - CONTOUR® | 2024-11-06 Control Solution - High, 1 x 2.5 mL |
Trademark Results [CONTOUR]
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