Duns Number:094651270
Device Description: Arterial Blood Collection Kit, 48", 6cc, w/o DPT
Catalog Number
902-635
Brand Name
N/A
Version/Model Number
Custom
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
b4403f43-8cea-47a8-a1f7-178e1d7566f1
Public Version Date
December 18, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
H6719026351
Quantity per Package
25
Contains DI Package
H6719026350
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 |