Composite Respiratory Kit: Performance Home Medical

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Composite Respiratory Kit: Performance Home Medical FDA UDI
Generic Name: Oxygen administration tubing FDA UDI
Device Name: Composite Respiratory Kit: Performance Home Medical 2-0194B, 2-0556B, 1-0027B, 1-0052B, 1-No Smoking Sign, 2-0590B FDA UDI
Model / Reference: 0836 FDA UDI
Description: Composite Respiratory Kit: Performance Home Medical 2-0194B, 2-0556B, 1-0027B, 1-0052B, 1-No Smoking Sign, 2-0590B FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078002540 FDA UDI
FDA Product Code: OGL FDA UDI
BYX FDA UDI
CAT FDA UDI
GMDN Term: Oxygen administration tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5655 FDA UDI
868.5860 FDA UDI
868.5340 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal oxygen cannula, basic Oxygen administration tubing Oxygen administration kit

Composite Respiratory Kit: Performance Home Medical by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Westmed, Inc.

Sources (1)

FDA UDI 19257907-b0eb-4154-8024-efcd06302b00 33 fields · synced Jun 8, 2026