Breathing bag anest disp 0.5L,compl - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Breathing bag anest disp 0.5L,compl

Version/Model Number

6694605

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

BTC

Product Code Name

Bag, Reservoir

Device Record Status

Public Device Record Key

b169dd67-c799-4514-9e75-cc91745728dd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 02, 2015

Additional Identifiers

Package DI Number

17325710002527

Quantity per Package

20

Contains DI Package

07325710002520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MAQUET CRITICAL CARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 131