Duns Number:010334675
Device Description: OR/ANESTHESIA CENTRAL LINE INSERTION KIT
Catalog Number
-
Brand Name
ACS
Version/Model Number
UIAN43J
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OFQ
Product Code Name
Anesthesia kit
Public Device Record Key
90a02053-485b-49b3-832a-9d4a4da22adf
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
July 21, 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 | 3339 |
2 | A medical device with a moderate to high risk that requires special controls. | 13185 |