Duns Number:079991657
Device Description: Regulator Washer
Catalog Number
7992
Brand Name
BOEHRINGER® Regulator Washer
Version/Model Number
7992
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 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
-
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
ea19ab0f-a531-4f48-b8a1-092b98f8fa57
Public Version Date
December 22, 2020
Public Version Number
4
DI Record Publish Date
September 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |