VentStar Breathing Bag 2L - Drägerwerk AG & Co. KGaA

Duns Number:315578914

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More Product Details

Catalog Number

-

Brand Name

VentStar Breathing Bag 2L

Version/Model Number

MP02712

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)

-

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

d39ff992-9973-4df8-b6b0-4e0b3d8d1d29

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 08, 2016

Additional Identifiers

Package DI Number

04048675441717

Quantity per Package

25

Contains DI Package

04048675389460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DRÄGERWERK AG & CO. KGAA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 220
2 A medical device with a moderate to high risk that requires special controls. 160