Duns Number:092673953
Device Description: Anesthesia Circuit, Adult, Uni-Lim, 60", Co-Axial, GSE, 3L Not Made With Latex Bag, 10' x Anesthesia Circuit, Adult, Uni-Lim, 60", Co-Axial, GSE, 3L Not Made With Latex Bag, 10' x .050' ID M/M GSL, 900 Series Large Adult Mask, HEPA Filter, In-Line Mini HMEF, Hose Clip
Catalog Number
-
Brand Name
Uni-Lim Coaxial Circuit
Version/Model Number
9153A
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
K922492,K922492
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
fb503073-ec2a-4c25-9aff-83d329c65462
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
February 26, 2021
Package DI Number
10709078012416
Quantity per Package
20
Contains DI Package
00709078012419
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |