FDA UDI
In Commercial Distribution
🇺🇸 United States
Valve, Bleed Tail
DI: 00709078010705
·
Model: 7-00675
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Valve, Bleed Tail
- Primary DI
- 00709078010705
- Version / Model
- 7-00675
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 1
- Public Version Date
- 2020-10-08
- Public Version Status
- New
- Public Device Record Key
- b3798f7f-06cf-47e7-b601-ca0c7a974fa3
Device Description
Valve, Bleed Tail, Bulk(100/Cs)
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 868.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46824 | Mechanical expiratory valve, single-use | A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit or system to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00709078010705 | GS1 | ||||
| Unit of Use | 10709078010719 | GS1 |