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iFlow

FDA UDI

Class II (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
iFlow FDA UDI
Generic Name
Breathing circuit gas-sampling/monitoring set FDA UDI
Device Name
iFlow 200 S Adult/Pediatric Proximal Flow Sensor FDA UDI
Model / Reference
301.328.020 FDA UDI
Description
iFlow 200 S Adult/Pediatric Proximal Flow Sensor FDA UDI

Identifiers

Catalog Number
301.328.020 FDA UDI
Primary DI / UDI-DI
10190752187818 FDA UDI
510(k) Number
K183364 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Breathing circuit gas-sampling/monitoring set 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing circuit gas-sampling/monitoring set

iFlow by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing circuit gas-sampling/monitoring set.

Cleared under the same submission

K183364 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vyaire Medical, Inc.

Sources (1)

  • FDA UDI d64f939a-adc3-45b3-8402-ae7f8c1eb26b 37 fields · synced Jun 8, 2026