Catalog Number

7620

Brand Name

BOEHRINGER® CareDry™ Regulator

Version/Model Number

7620

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2020

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KDP

Product Code Name

Regulator, Vacuum

Public Device Record Key

f025a3b0-55cd-49a2-8e56-ee16f397824f

Public Version Date

December 16, 2020

Public Version Number

2

DI Record Publish Date

December 01, 2019

Package DI Number

70816286020927

Quantity per Package

10

Contains DI Package

10816286020925

Package Discontinue Date

November 18, 2020

Package Status

Not in Commercial Distribution

Package Type

Box