Primary Device ID | 10365702703251 |
NIH Device Record Key | 5c199778-f4de-4253-999a-1d8d6d8553a4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACCU-CHECK GUIDE |
Version Model Number | 10439238001 |
Catalog Number | 10439238001 |
Company DUNS | 141608724 |
Company Name | Roche Diagnostics Operations, Inc. |
Device Count | 2 |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00365702703254 [Primary] |
GS1 | 10365702703251 [Package] Contains: 00365702703254 Package: [24 Units] In Commercial Distribution |
GS1 | 50365702703259 [Unit of Use] |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-28 |
Device Publish Date | 2025-03-20 |
00365702703209 - ACCU-CHEK GUIDE | 2025-03-28 VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE |
10365702703213 - ACCU-CHEK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH VALUE KIT |
10365702703237 - ACCU-CHEK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH US 30CT STRIP |
10365702703251 - ACCU-CHECK GUIDE | 2025-03-28ACCU-CHEK GUIDE CASH US 60CT STRIP |
10365702703251 - ACCU-CHECK GUIDE | 2025-03-28 ACCU-CHEK GUIDE CASH US 60CT STRIP |
00365702702417 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118 |
10365702702889 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US |
10365702702476 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link SC mg/dL |
10365702702537 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link MO Replacement US |