Duns Number:595138793
Catalog Number
689361
Brand Name
SAFEDRAW TA4812SDT BLUE
Version/Model Number
689361
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 10, 2017
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
DSK
Product Code Name
Computer, Blood-Pressure
Public Device Record Key
19405524-685a-4127-b923-367072204328
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2017
Package DI Number
50886333693615
Quantity per Package
10
Contains DI Package
00886333693610
Package Discontinue Date
April 10, 2017
Package Status
Not in Commercial Distribution
Package Type
Tyvek Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |