BE 1000-2 O2 Instant Flow Valve Bag Hanger

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: BE 1000-2 O2 Instant Flow Valve Bag Hanger FDA UDI
Generic Name: Respiratory oxygen therapy system FDA UDI
Device Name: BE 1000-2 Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Reusable. FDA UDI
Model / Reference: BE 1000-2 FDA UDI
Description: BE 1000-2 Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Reusable. FDA UDI

Identifiers

Catalog Number: BE 1000-2 FDA UDI
Primary DI / UDI-DI: M996BE100020 FDA UDI
510(k) Number: K970959 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Respiratory oxygen therapy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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: Respiratory oxygen therapy system

BE 1000-2 O2 Instant Flow Valve Bag Hanger by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory oxygen therapy system.

02-RESQ — Pulmodyne Inc. · Class II
02-RESQ — Pulmodyne Inc. · Class II
GO-PAP — Pulmodyne Inc. · Class II
O2-RESQ — Pulmodyne Inc. · Class II
HI-OXYGEN MASK ADULT W/O VALVE, WITH 7FT TUBE, SINGLE PACKING — BESMED HEALTH BUSINESS CORP. · Class I
O2-MAX — Pulmodyne Inc. · Class II
Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
AincA — Anesthesia Associates, Inc. · Class II

Cleared under the same submission

K970959 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 022854cf-a6dc-454b-adee-c393d78be8c4 36 fields · synced May 30, 2026