Device Respiratory Accessory Kit

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Device Respiratory Accessory Kit FDA UDI
Generic Name: Partial-rebreathing oxygen face mask FDA UDI
Device Name: Respiratory Accessory Kit- Adult & Pediatric Mask FDA UDI
Model / Reference: 0791 FDA UDI
Description: Respiratory Accessory Kit- Adult & Pediatric Mask FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078009167 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Partial-rebreathing oxygen face mask FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5580 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Partial-rebreathing oxygen face mask

Device Respiratory Accessory Kit by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partial-rebreathing oxygen face mask.

HUDSON RCI — TELEFLEX INCORPORATED · Class I
Resp-O2 Oxygen Mask Medium-Concentration, Elongated Pediatric — Dynarex Corp. · Class I
Resp-O2 Oxygen Mask Medium-Concentration, Elongated Pediatric — Dynarex Corp. · Class I
Resp-O2 Oxygen Mask Medium-Concentration, Standard Adult — Dynarex Corp. · Class I
Resp-O2 Oxygen Mask Medium-Concentration, Standard Pediatric — Dynarex Corp. · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
Resp-O2 Oxygen Mask Medium-Concentration, Elongated Adult — Dynarex Corp. · Class I
RUSCH — TELEFLEX INCORPORATED · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Westmed, Inc.

Sources (1)

FDA UDI d0e7bfab-fcfe-4f89-90ce-2b2a0fe16738 33 fields · synced May 31, 2026