Duns Number:092673953
Device Description: 72" Adult Uni-Lim™, GSE, Maxi HMEF, 3Lf, 48" Drop Line
Catalog Number
-
Brand Name
Uni-Lim Coaxial Circuit
Version/Model Number
9416
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"
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
0a11621f-bd36-4163-b053-fcb1bb987004
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
July 31, 2019
Package DI Number
10709078007597
Quantity per Package
20
Contains DI Package
00709078007590
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |