FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Portable Oxygen Liter Meter
DI: 00840117318694
·
Model: 33309
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
15
Basic Information
- Brand Name
- Resp-O2 Portable Oxygen Liter Meter
- Primary DI
- 00840117318694
- Version / Model
- 33309
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- 52298490-8b69-48f2-be55-ab0111736975
Device Description
Resp-O2 Portable Oxygen Liter Meter
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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | Anesthesiology | 868.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35910 | Portable liquid oxygen unit | An empty device designed as a portable, supplemental, refillable container intended as a storage for liquid oxygen (LOX) and its conversion into gaseous form for delivery of medical oxygen (O2) at various pulsed or fixed flow settings to a patient who typically has difficulty extracting O2 from the atmosphere. It typically consists of a cryogenic canister containing the LOX, a mechanism (e.g., a warming coil) where the LOX is converted into gas, a gas delivery control device (e.g., demand valve or fixed flow mechanism) that regulates the flow of O2 to the patient, a fill port and an outlet connection for connection of a nasal cannula or face mask. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117318618 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00840117318694 | GS1 | ||||
| Unit of Use | 00840117319899 | GS1 |