FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Chek Inform II Base Unit Light
DI: 07613336155318
·
Model: 08376824190
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accu-Chek Inform II Base Unit Light
- Primary DI
- 07613336155318
- Version / Model
- 08376824190
- Catalog Number
- 08376824190
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5d5f1b92-f2ab-44d0-ba3a-225f9ce874d6
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56669 | Metabolic profile clinical chemistry analyser IVD, stationary, automated | A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2)], electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and complete automation of all procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336155318 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121679 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius