Duns Number:079991657
Device Description: CareDry™ Wand
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
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
a3570832-5574-4777-92b1-4d79e32d2d57
Public Version Date
April 02, 2021
Public Version Number
2
DI Record Publish Date
January 01, 2021
Package DI Number
70816286021030
Quantity per Package
10
Contains DI Package
10816286021038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |