FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gas mixture cylinder
DI: 05700699621061
·
Model: 962-106
·
Radiometer Medical ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gas mixture cylinder
- Primary DI
- 05700699621061
- Version / Model
- 962-106
- Catalog Number
- 962-106
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 49361fa7-7937-4bae-a3d6-721c55658b52
- Distribution End Date
- 2016-09-28
Device Description
Gas mixture cylinder 1 litre 5% CO2, 20.9% O2, balance: N2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BXK | GAS, CALIBRATION (SPECIFIED CONCENTRATION) | Anesthesiology | 868.6400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36346 | Transcutaneous blood gas monitor, paediatric | A mains electricity (AC-powered) device designed for the continuous, transcutaneous (through the skin) measure of the partial pressure of oxygen (pO2) and the partial pressure of carbon dioxide (pCO2) in a paediatric patient's blood. It includes a special sensor that is typically heated to increase the blood flow and gas diffusion at the point of application on the skin's surface. The gas then diffuses through the membrane of the sensor and is measured by the device; results are digitally displayed and/or printed. This device is especially used to measure and display pO2/pCO2 in infants not under gas anaesthesia. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699621061 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- To be protected from light or heat
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius