Duns Number:079991657
Device Description: Replacement Plastic Bottle for 9101 Trap
Catalog Number
34059
Brand Name
BOEHRINGER® Replacement Plastic Bottle for 9101 Trap
Version/Model Number
34059
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
-
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
b2ce3887-79fb-40fa-9862-27d8422ef9c3
Public Version Date
August 23, 2018
Public Version Number
3
DI Record Publish Date
November 27, 2017
Package DI Number
40816286020766
Quantity per Package
6
Contains DI Package
10816286020765
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 |