Philips Respironics - V60 Ventilator, English Opt: None - Respironics California, Inc.

Duns Number:079550876

Device Description: V60 Ventilator, English Opt: None

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More Product Details

Catalog Number

1053616

Brand Name

Philips Respironics

Version/Model Number

V60

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MNT

Product Code Name

Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

Device Record Status

Public Device Record Key

4a9c2b0c-0f23-4e05-a1e6-1041e9d5bf78

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

October 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS CALIFORNIA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33