FDA UDI
In Commercial Distribution
🇺🇸 United States
CO2GEN COMPACT (20 PER PACK)
DI: 05032384123261
·
Model: CD0020C
·
OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CO2GEN COMPACT (20 PER PACK)
- Primary DI
- 05032384123261
- Version / Model
- CD0020C
- Company Name
- OXOID LIMITED
- Labeler DUNS
- 365355452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 6a298edf-f909-4f46-ad2f-6e1c92688206
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
- Yes
- 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 |
|---|---|---|---|---|
| KZJ | Device, Gas Generating | Microbiology | 866.2580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43520 | Atmospheric generation kit IVD | A pouch, unit, and/or other accessories intended to be used in combination to generate specific atmospheric conditions [e.g., increased carbon dioxide (CO2), reduced or depleted oxygen (AnO2)] as an environment suitable for the cultivation, processing, or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05032384123261 | GS1 |