FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFE®OxygenPac
DI: B188LIFE6FF0
·
Model: LIFE-6FF
·
Mv Life LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LIFE®OxygenPac
- Primary DI
- B188LIFE6FF0
- Version / Model
- LIFE-6FF
- Company Name
- Mv Life LLC
- Labeler DUNS
- 096584064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-29
- Public Version
- 4
- Public Version Date
- 2024-09-16
- Public Version Status
- Update
- Public Device Record Key
- ff0484d5-0587-451b-ba26-435106ea09d4
Device Description
LIFE®OxygenPac is an easily portable, wall-mounted Emergency Oxygen Unit. A fixed-flow regulator provides a 90 minute supply of oxygen at 6LPM.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31760 | Fixed-regulator oxygen refillable cylinder | A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B188LIFE6FF0 | HIBCC |
Customer Contacts
- Phone
- 1-800-700-0202
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 566 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 125 Degrees Fahrenheit