Catalog Number

7630

Brand Name

BOEHRINGER® CareDry™ Regulator PST

Version/Model Number

7630

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

06b3195c-4042-489e-98ca-fdb541d3fd47

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

70816286020941

Quantity per Package

10

Contains DI Package

10816286020949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box