Identity
- Trade Name
- BE 131 One-Way Valve FDA UDI
- Generic Name
- Non-rebreathing valve, reusable FDA UDI
- Device Name
- The reusable BE 131 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source. The device includes a silicone rubber connector with 22mm I.D. Inlet. FDA UDI
- Model / Reference
- BE 131 FDA UDI
- Description
- The reusable BE 131 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source. The device includes a silicone rubber connector with 22mm I.D. Inlet. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996BE1310 FDA UDI
- 510(k) Number
- K970780 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Non-rebreathing valve, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing valve, reusable
BE 131 One-Way Valve by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI dc7fda70-1428-4d5c-8830-31232cd74df8 34 fields · synced May 30, 2026