FDA UDI
In Commercial Distribution
🇺🇸 United States
Liberator
DI: M76613258641SM0
·
Model: 13258641SM
·
CAIRE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Liberator
- Primary DI
- M76613258641SM0
- Version / Model
- 13258641SM
- Company Name
- CAIRE INC.
- Labeler DUNS
- 807537683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-06
- Public Version
- 1
- Public Version Date
- 2020-08-14
- Public Version Status
- New
- Public Device Record Key
- 3c2473a2-6d30-466b-9b52-2189abbc4ba7
Device Description
Base Liquid Oxygen Respiratory Equipment, Top Fill, 15 LPM, 20 PSI, Short Inner
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | Anesthesiology | 868.5655 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35221 | Stationary liquid oxygen container | An empty device designed as a large reservoir for the storage of liquid oxygen (LOX) prior to its distribution and use. It typically consists of a large capacity (e.g., 10 or 100 litres) double vessel bulk tank (i.e., an inner vessel to contain the liquid oxygen and an outer vessel for protection); vacuum in the space between both vessels provides thermal insulation for the LOX. The container typically includes evaporation coils that slowly boil the LOX into gas and is used in supply centres and in most large healthcare facilities before the distribution of LOX either as liquid or gas; some smaller containers are used at home to fill portable liquid oxygen units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M76613258641SM0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800742 | 000 |