Duns Number:595138793
Catalog Number
682145/A
Brand Name
Safedraw™
Version/Model Number
10884450326449
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)
-
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
c251be39-51cd-4d11-93e7-a257c461f926
Public Version Date
December 13, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2019
Package DI Number
20884450326446
Quantity per Package
10
Contains DI Package
10884450326449
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |