FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Soft Plus CO2 Sampling Nasal Cannula
DI: 00709078005633
·
Model: 0441F
·
WESTMED, INC.
Product Codes
3
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Comfort Soft Plus CO2 Sampling Nasal Cannula
- Primary DI
- 00709078005633
- Version / Model
- 0441F
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 3
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 85de6251-6229-48d9-b5df-6f902c45965c
Device Description
Pediatric Nasal Cannula, O2/CO2 Sampling Line w/Female Luers, 0.8 Micron Filter
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12875 | Oxygen administration tubing | A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device. | No | Active |
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | 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 simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078005630 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00709078005633 | GS1 |