BOEHRINGER® Suction Regulator, MRI Conditional & Safe Continuous, 0-200, off/reg - Suction Regulator, MRI Conditional & Safe - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: Suction Regulator, MRI Conditional & Safe Continuous, 0-200, off/reg/line

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

3708

Brand Name

BOEHRINGER® Suction Regulator, MRI Conditional & Safe Continuous, 0-200, off/reg

Version/Model Number

3708

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

09a6d291-9573-4957-8758-3b7c8c421d0a

Public Version Date

August 23, 2018

Public Version Number

3

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