PHILIPS - KIT,O2 TRANSPORT,CART MTG,DISS-M - Respironics California, Inc.

Duns Number:079550876

Device Description: KIT,O2 TRANSPORT,CART MTG,DISS-M

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More Product Details

Catalog Number

989805648241

Brand Name

PHILIPS

Version/Model Number

1109602

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

1b066405-1e81-4943-9cbd-7359b81151a9

Public Version Date

December 07, 2020

Public Version Number

2

DI Record Publish Date

September 22, 2020

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