FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gas Sampling Line
DI: 00709078007897
·
Model: 0510
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Gas Sampling Line
- Primary DI
- 00709078007897
- Version / Model
- 0510
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-18
- Public Version
- 4
- Public Version Date
- 2023-03-31
- Public Version Status
- Update
- Public Device Record Key
- 45c7e1af-6534-48f4-8614-2fab85bff3ee
- Distribution End Date
- 2023-03-31
Device Description
Gas Sampling Line, 10' X .060 ID X .108 OD M/F Luers
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
- 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 |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | 868.5975 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078007894 | GS1 | 50 | Not in Commercial Distribution | 2023-03-31 | |
| Primary | 00709078007897 | GS1 |