CONTOUR® NEXT GEN 90002902
GUDID 00301937917011
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card.
ASCENSIA DIABETES CARE US INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 00301937917011 |
| NIH Device Record Key | fcdd595c-e7fd-4d13-a93b-f90362e6c0c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONTOUR® NEXT GEN |
| Version Model Number | 7917 |
| Catalog Number | 90002902 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301937917011 [Primary] |
| GS1 | 40301937917019 [Package] Package: shipper/case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193407
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-11 |
| Device Publish Date | 2022-07-01 |
On-Brand Devices [CONTOUR® NEXT GEN]
| 40301939658019 | "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood |
| 40301937383012 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
| 00301937917011 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
| 40301939732016 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
| 40301937922013 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
| 40301939732023 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
Trademark Results [CONTOUR]
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