Duns Number:092673953
Device Description: Pediatric Circuit, 120" Expandable Tubing
Catalog Number
-
Brand Name
Disposable Anesthesia Circuits
Version/Model Number
9392
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
b04fffba-88e0-495e-a382-bf43f86ec56f
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2021
Package DI Number
10709078013857
Quantity per Package
20
Contains DI Package
00709078013850
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 |