O2-Cpap

FDA UDI

Class II (US FDA UDI)

by Pulmodyne Inc.

Identity

Trade Name: O2-CPAP FDA UDI
Generic Name: PEEP valve, single-use FDA UDI
Model / Reference: 313-7720 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841470111052 FDA UDI
510(k) Number: K983920 FDA UDI
FDA Product Code: BYE FDA UDI
GMDN Term: PEEP valve, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5965 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: PEEP valve, single-use

O2-Cpap by Pulmodyne Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as PEEP valve, single-use.

PEEP VALVE 5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
PEEP VALVE 2.5cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
PEEP VALVE 10cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
AirLife™ — Airlife, Inc. · Class II
Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II
PEEP VALVE 15cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II

Cleared under the same submission

K983920 also covers:

APV- Adjustable PEEP Valve — Engineered Medical Systems, LLC
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP — Pulmodyne Inc.
O2-CPAP Valve — Pulmodyne Inc.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Pulmodyne Inc.

Sources (1)

FDA UDI c331da9b-fb77-44fc-a30e-cd7fa226f14c 34 fields · synced May 30, 2026