BOEHRINGER® AUTOVAC® Modular Collection Module with Disconnect - AUTOVAC® Modular Collection Module with - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: AUTOVAC® Modular Collection Module with Disconnect

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More Product Details

Catalog Number

792600

Brand Name

BOEHRINGER® AUTOVAC® Modular Collection Module with Disconnect

Version/Model Number

792600

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2017

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"

Yes

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

K932093,K932093

Product Code Details

Product Code

CAC

Product Code Name

Apparatus, Autotransfusion

Device Record Status

Public Device Record Key

4ed68919-4941-4eaa-865e-b269b6c12f59

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

40816286020667

Quantity per Package

6

Contains DI Package

10816286020666

Package Discontinue Date

September 01, 2017

Package Status

Not in Commercial Distribution

Package Type

Box

"BOEHRINGER LABORATORIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 85