FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 50822383132452
·
Model: 18146
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 50822383132452
- Version / Model
- 18146
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 3
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- beb0d914-bba2-4d09-aceb-9bf3e0ad99d5
- Distribution End Date
- 2024-01-29
Device Description
RespiratoryCarts/racks/cases/stands Product Description: Oxy Cyl.Carrier, E,D,Fits4, 2/cs
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
- Yes
- 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 |
|---|---|---|---|---|
| PCM | Portable liquid oxygen unit stand | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47225 | Oxygen refillable cylinder | A container designed as a refillable cylinder 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 valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials and must be used together with a pressure regulator in order to release the O2 at the correct working pressure. 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 |
|---|---|---|---|---|---|---|
| Package | 00822383132457 | GS1 | 2 | Not in Commercial Distribution | 2024-01-29 | |
| Primary | 50822383132452 | GS1 |