Duns Number:079991657
Device Description: Disposable Regulator 100-150mmHg
Catalog Number
7650
Brand Name
BOEHRINGER® Disposable Regulator 100-150mmHg
Version/Model Number
7650
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
4c3bcaf9-7757-4e89-9c37-42fe3bd9f366
Public Version Date
April 15, 2020
Public Version Number
1
DI Record Publish Date
April 07, 2020
Package DI Number
30816286021018
Quantity per Package
5
Contains DI Package
10816286021014
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 |