BOEHRINGER® CareDry™ Wand - CareDry™ Wand - BOEHRINGER LABORATORIES, LLC

Duns Number:079991657

Device Description: CareDry™ Wand

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More Product Details

Catalog Number

7640

Brand Name

BOEHRINGER® CareDry™ Wand

Version/Model Number

7640

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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 Details

Product Code

KDP

Product Code Name

Regulator, Vacuum

Device Record Status

Public Device Record Key

a3570832-5574-4777-92b1-4d79e32d2d57

Public Version Date

April 02, 2021

Public Version Number

2

DI Record Publish Date

January 01, 2021

Additional Identifiers

Package DI Number

70816286021030

Quantity per Package

10

Contains DI Package

10816286021038

Package Discontinue Date

-

Package Status

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