← Back to catalogue

FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit FDA UDI
Generic Name
Stationary angiographic x-ray system, analogue FDA UDI
Model / Reference
9571 FDA UDI

Identifiers

Primary DI / UDI-DI
00709078004414 FDA UDI
510(k) Number
K922492 FDA UDI
FDA Product Code
OFP FDA UDI
OGL FDA UDI
CAH FDA UDI
GMDN Term
Stationary angiographic x-ray system, analogue FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5240 FDA UDI
868.5655 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

Yes

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 Co-Flo, Disposable Heated Humidified Circuit Kit 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

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

Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI 4530c0de-fa8e-4063-8cad-6cec06524fcc 34 fields · synced May 31, 2026