Duns Number:092673953
Device Description: 60" Adult Coaxial Circuit, Anesthesia Breathing Circuit W/24" Flex Expiratory Lead, GSE W/ 60" Adult Coaxial Circuit, Anesthesia Breathing Circuit W/24" Flex Expiratory Lead, GSE W/Cap, B/V Filter, 3L Latex Free Breathing Bag
Catalog Number
-
Brand Name
Uni-Lim Coaxial Circuit
Version/Model Number
6654
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
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
6467140a-7233-43dd-af99-ec2e67068cf3
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
May 15, 2020
Package DI Number
10709078008488
Quantity per Package
20
Contains DI Package
00709078008481
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 |