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Philips

FDA UDI

Class II (US FDA UDI)

by Respironics California, Inc.

Identity

Trade Name
PHILIPS FDA UDI
Generic Name
Portable electric ventilator FDA UDI
Device Name
V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV FDA UDI
Model / Reference
1053613 FDA UDI
Description
V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV FDA UDI

Identifiers

Catalog Number
1053613 FDA UDI
Primary DI / UDI-DI
00884838009844 FDA UDI
FDA Product Code
MNT FDA UDI
GMDN Term
Portable electric ventilator 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Portable electric ventilator

Philips by Respironics California, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable electric ventilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics California, Inc.

Sources (1)

  • FDA UDI 3f493ebd-abb5-472b-b48f-b66bb241d5ea 36 fields · synced May 29, 2026