Duns Number:092673953
Device Description: Pulset 1cc Syringe, 25g x 5/8" (.5 x 15.9mm) Crickett, ~25u Balanced Heparin, Vented Luer
Catalog Number
-
Brand Name
Blood Gas Sampler
Version/Model Number
3105-95VT
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
07c9ec7b-6ced-4a3c-8765-e5f30e650d88
Public Version Date
September 30, 2022
Public Version Number
3
DI Record Publish Date
May 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |