FDA UDI
In Commercial Distribution
🇺🇸 United States
Nasal Oxygen Cannula
DI: 00850014433154
·
Model: 1
·
DISTRIBUTION UNLIMITED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nasal Oxygen Cannula
- Primary DI
- 00850014433154
- Version / Model
- 1
- Catalog Number
- DU1010
- Company Name
- DISTRIBUTION UNLIMITED, LLC
- Labeler DUNS
- 926603486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 1
- Public Version Date
- 2020-08-21
- Public Version Status
- New
- Public Device Record Key
- d9b58f0e-2e0d-4eaa-89e6-29de24943ba5
Device Description
The nasal cannula is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46867 | Oxygen administration enhancement device | A non-sterile device intended to be used to rapidly provide a supply of inhaled oxygen (O2) at higher than normal concentrations (e.g., FiO2 concentrations of 70% at 6L/min), typically for a patient during recovery [e.g., in the operating room (OR)]. It typically includes tubing that connects directly to an O2 source, a reservoir bag that concentrates the O2 and enables confirmation of respiration through its movement, a coupling that connects into an artificial airway already in situ, and a port for exhalation of gases. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850014433154 | GS1 | ||||
| Package | 20850014433158 | GS1 | CASE | 100 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Feet |