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FloEasy

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
FloEasy FDA UDI
Generic Name
Anaesthesia breathing circuit, single-use FDA UDI
Device Name
FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit FDA UDI
Model / Reference
9571HTS FDA UDI
Description
FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00709078013836 FDA UDI
510(k) Number
K922492 FDA UDI
FDA Product Code
OFP FDA UDI
CAH FDA UDI
GMDN Term
Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5240 FDA UDI
868.5260 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

FloEasy by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K922492 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI d22636d3-ddb4-44f6-bda6-703647b67dca 35 fields · synced May 30, 2026