FDA UDI
In Commercial Distribution
🇺🇸 United States
Endure
DI: B531NCX220
·
Model: NCX221217
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Endure
- Primary DI
- B531NCX220
- Version / Model
- NCX221217
- Catalog Number
- NCX22
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-20
- Public Version
- 3
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 849a3b26-f5f4-4832-b0ed-0f7d081a533d
Device Description
Nasal Oxygen Cannula, Size Extra Large, Length 2 Meters
Device Characteristics
- Single Use
- Yes
- 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
- 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
- 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 |
|---|---|---|---|---|
| 35201 | Nasal oxygen cannula, basic | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B531NCX222 | HIBCC | Carton | 50 | In Commercial Distribution | |
| Primary | B531NCX220 | HIBCC |
Customer Contacts
- Phone
- 6072994971
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2 | Meter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius