BOEHRINGER® Regulator Horizontal Dual Mount - Regulator Horizontal Dual Mount - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: Regulator Horizontal Dual Mount

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More Product Details

Catalog Number

9062

Brand Name

BOEHRINGER® Regulator Horizontal Dual Mount

Version/Model Number

9062

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

KDP

Product Code Name

Regulator, Vacuum

Device Record Status

Public Device Record Key

6aacf9b5-38af-46c5-8c1f-53b0912f4bc8

Public Version Date

April 02, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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