Duns Number:092673953
Device Description: Full Kit, Pulset 1cc syringe 23g x 1" (.6 x 25mm) Q-Cork, 25u Balanced Herparin (Case of 1 Full Kit, Pulset 1cc syringe 23g x 1" (.6 x 25mm) Q-Cork, 25u Balanced Herparin (Case of 100)
Catalog Number
-
Brand Name
Pulset
Version/Model Number
3193CH
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 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
CBT
Product Code Name
Arterial Blood Sampling Kit
Public Device Record Key
7da35a93-b782-4d38-b0a4-8690f4e5d316
Public Version Date
September 30, 2022
Public Version Number
4
DI Record Publish Date
June 30, 2019
Package DI Number
10709078006552
Quantity per Package
100
Contains DI Package
00709078006555
Package Discontinue Date
September 30, 2022
Package Status
Not 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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |