WhisperPak, M520 H113 T2m, Case 10 - Respironics Novametrix, LLC

Duns Number:093608594

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More Product Details

Catalog Number

4-100069-00

Brand Name

WhisperPak, M520 H113 T2m, Case 10

Version/Model Number

00

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

Yes

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

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Device Record Status

Public Device Record Key

345c053c-1023-47bd-8e94-4489d9e686b4

Public Version Date

June 24, 2021

Public Version Number

5

DI Record Publish Date

September 01, 2017

Additional Identifiers

Package DI Number

30884838075550

Quantity per Package

10

Contains DI Package

00884838075559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multipack

"RESPIRONICS NOVAMETRIX, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 61