FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gas Sampling Line
DI: 00709078007040
·
Model: 0802
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- Gas Sampling Line
- Primary DI
- 00709078007040
- Version / Model
- 0802
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2021-12-24
- Public Version
- 4
- Public Version Date
- 2023-03-31
- Public Version Status
- Update
- Public Device Record Key
- 3858e893-61c4-4608-8ca9-ac95752d9997
- Distribution End Date
- 2023-03-31
Device Description
10' PVC, .050" ID X .108" OD M/M Luers, Bulk
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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10709078013727 | GS1 | ||||
| Primary | 00709078007040 | GS1 |