Breath bag set Anest 15mm Hytrel - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Breath bag set Anest 15mm Hytrel

Version/Model Number

6692192

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

BTC

Product Code Name

Bag, Reservoir

Device Record Status

Public Device Record Key

c684f0ca-3dfa-492a-a623-f439c03a8754

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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