FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ACCU-CHEK AVIVA COMBO
DI: 00365702647107
·
Model: 05075645005
·
Roche Diagnostics Operations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCU-CHEK AVIVA COMBO
- Primary DI
- 00365702647107
- Version / Model
- 05075645005
- Company Name
- Roche Diagnostics Operations, Inc.
- Labeler DUNS
- 141608724
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 3
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- bf922d9e-2c93-4bf9-9275-1b52648955c8
- Distribution End Date
- 2021-10-18
Device Description
ACCU-CHEK AVIVA COMBO MG/DL (670)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62645 | Glucose analyser IVD, home-use | An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00365702647107 | GS1 |