BiTrac Vented

FDA UDI

Class II (US FDA UDI)

by Pulmodyne Inc.

Identity

Trade Name: BiTrac Vented FDA UDI
Generic Name: CPAP/BPAP nasal mask, single-use FDA UDI
Model / Reference: 313-9155 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841470107093 FDA UDI
510(k) Number: K972605 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: CPAP/BPAP nasal mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 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: CPAP/BPAP nasal mask, single-use

BiTrac Vented by Pulmodyne Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP nasal mask, single-use.

PN841 — Respironics, Inc. · Class II
Flow-Safe II Disposable CPAP System — MERCURY ENTERPRISES, INC. · Class II
PN841 — Respironics, Inc. · Class II
FitStar Hospital Nasal Non Vented Mask, s/m — Sleepnet Corporation · Class II
Whisper Soft — Engineered Medical Systems, LLC · Class II
AirLife™ — Airlife, Inc. · Class II
Flow-Safe II EZ Disposable CPAP System — MERCURY ENTERPRISES, INC. · Class II
SuperNO2VA — Airlife, Inc. · Class II

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

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

Manufacturer

Manufacturer: Pulmodyne Inc.

Sources (1)

FDA UDI 831a0ef4-83d0-44b0-b066-bb0ac79b1002 35 fields · synced May 30, 2026