Af531

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: AF531 FDA UDI
Generic Name: CPAP/BPAP face mask, single-use FDA UDI
Device Name: AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use FDA UDI
Model / Reference: AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use FDA UDI
Description: AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use FDA UDI

Identifiers

Catalog Number: 1119010 FDA UDI
Primary DI / UDI-DI: 00606959004597 FDA UDI
FDA Product Code: MNS FDA UDI
GMDN Term: CPAP/BPAP face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 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

FDA UDI

Manufacturing Date

FDA UDI

Category: CPAP/BPAP face mask, single-use

Af531 by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BiTrac SE Select — Pulmodyne Inc. · Class II

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: Respironics, Inc.

Sources (1)

FDA UDI 176afd54-d2d9-4765-bd82-f18be79970bf 36 fields · synced May 30, 2026