Duns Number:595138793
Device Description: A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 60” Pressure Tu A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
Catalog Number
682145
Brand Name
SAFEDRAW(TM) TA6012SDT
Version/Model Number
682145
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)
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
2fd31cde-5c84-48fd-84f1-502b498488de
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333621458
Quantity per Package
50
Contains DI Package
00886333621453
Package Discontinue Date
-
Package Status
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 |