Duns Number:094651270
Device Description: Arterial Blood Collection System Stand Alone, to be used with a Disposable Pressure Transd Arterial Blood Collection System Stand Alone, to be used with a Disposable Pressure Transducer
Catalog Number
ABC-048
Brand Name
N/A
Version/Model Number
PLUS ABC KIT
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"
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
bb9d8ba6-4c95-42ad-b7cd-2419b91366f7
Public Version Date
December 18, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
H671ABC0481
Quantity per Package
25
Contains DI Package
H671ABC0480
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 |