FDA UDI
In Commercial Distribution
🇺🇸 United States
BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2)
DI: 05055273227116
·
Model: BG5002
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2)
- Primary DI
- 05055273227116
- Version / Model
- BG5002
- Catalog Number
- BG5002
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-04
- Public Version
- 1
- Public Version Date
- 2019-06-12
- Public Version Status
- New
- Public Device Record Key
- 75c9b98a-ab5c-47d9-aaab-406b63c0c586
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30218 | Multiple blood gas analyte IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273227116 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093384 | 000 |