FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve
DI: 00840117338135
·
Model: 36394
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve
- Primary DI
- 00840117338135
- Version / Model
- 36394
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 2
- Public Version Date
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- 34853454-88e1-4e8d-b45c-42203eb74e92
Device Description
Standard: Dot -3AL, Nominal Working Pressure; 139 (BAR), Hydraulic Test Pressure: 232 (BAR), Material: Aluminum alloy 6061, Actual Weight: 2.8 (kg), Actual Volume: 2.89 (L)
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ECX | Cylinder, Compressed Gas, And Valve | Anesthesiology | 868.2700 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00840117338135 | GS1 |