Duns Number:094651270
Device Description: Arterial Blood Collection (ABC) System, Vacuum Collection Sampling System with Protected C Arterial Blood Collection (ABC) System, Vacuum Collection Sampling System with Protected Cannula
Catalog Number
ABC-105
Brand Name
N/A
Version/Model Number
ACCESSORY
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
CBT
Product Code Name
Arterial Blood Sampling Kit
Public Device Record Key
fc870024-80aa-4df6-ad10-ce7397abcd58
Public Version Date
December 18, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
H671ABC1051
Quantity per Package
50
Contains DI Package
H671ABC1050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |