BE 130-22B One-way Valve

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: BE 130-22B One-way Valve FDA UDI
Generic Name: Non-rebreathing valve, reusable FDA UDI
Device Name: The reusable BE 130-22B 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. FDA UDI
Model / Reference: BE 130-22B FDA UDI
Description: The reusable BE 130-22B 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. FDA UDI

Identifiers

Primary DI / UDI-DI: M996BE13022B0 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Non-rebreathing valve, reusable

BE 130-22B 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

K970780 also covers:

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 a29e1eb9-d35a-4b13-b99d-1ab46368221b 35 fields · synced May 30, 2026