Duns Number:080935429
Device Description: B.BRAWN 1 ML AMBER BARREL ORAL MEDICATION SYRINGE W/CAP
Catalog Number
8881882712T
Brand Name
Magellan
Version/Model Number
8881882712T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
34c7be96-0084-464d-86ec-d71d977d4069
Public Version Date
August 24, 2021
Public Version Number
6
DI Record Publish Date
November 21, 2017
Package DI Number
20884521152653
Quantity per Package
800
Contains DI Package
10884521152656
Package Discontinue Date
July 01, 2023
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |