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Infant Flow SiPAP

FDA UDI

Class II (US FDA UDI)

by Vyaire Medical, Inc.

Identity

Trade Name
Infant Flow SiPAP FDA UDI
Generic Name
Neonatal intensive-care ventilator FDA UDI
Device Name
KIT,SIPAP,IF,COMP,AUX,FDISS,ENGLISH FDA UDI
Model / Reference
27428-001 FDA UDI
Description
KIT,SIPAP,IF,COMP,AUX,FDISS,ENGLISH FDA UDI

Identifiers

Catalog Number
27428-001 FDA UDI
Primary DI / UDI-DI
10190752161924 FDA UDI
510(k) Number
K031745 FDA UDI
FDA Product Code
BZD FDA UDI
GMDN Term
Neonatal intensive-care ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neonatal intensive-care ventilator

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

Similar devices

Also classified as Neonatal intensive-care ventilator.

Cleared under the same submission

K031745 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 4608b4ea-9348-40a3-869f-36fea6106f00 36 fields · synced May 30, 2026