Duns Number:002397347
Device Description: ALLERGAN 21 GA. WINGED INFUSION SET
Catalog Number
7A3843
Brand Name
B.BRAUN
Version/Model Number
7A3843
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2022
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"
Yes
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
LCJ
Product Code Name
EXPANDER, SKIN, INFLATABLE
Public Device Record Key
92e97980-ab7b-45e9-99b3-1a350d2305bb
Public Version Date
February 24, 2022
Public Version Number
5
DI Record Publish Date
October 11, 2015
Package DI Number
04046964338472
Quantity per Package
10
Contains DI Package
04046964787119
Package Discontinue Date
February 22, 2022
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |