FDA UDI
In Commercial Distribution
🇺🇸 United States
Accutrend Plus Meter Kit
DI: 04015630946365
·
Model: 07769202001
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accutrend Plus Meter Kit
- Primary DI
- 04015630946365
- Version / Model
- 07769202001
- Catalog Number
- 07769202001
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 4802aeba-2a05-4dc6-92ea-ad0de8411ea6
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58436 | Point-of-care blood glucose monitoring system | An assembly of devices intended to be operated by a healthcare professional to continually measure patient blood glucose at the point-of-care in a healthcare facility. It is continuously connected to the patient during use and typically consists of a line-powered control unit, with user interface and rechargeable battery, containing a spectrometer to quantitatively measure glucose concentration in received plasma samples; a sterile, single-use cartridge connected to the patient via a venous catheter designed to withdraw a blood sample at intervals, convert it to plasma, and transport it to the control unit for analysis; a heparin syringe; and a sterile cap to protect the patient connector. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04015630946365 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051376 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius