Duns Number:092673953
Device Description: Respiratory Circuit, Adult, 72", Bi-Wye W/Temp Port, 2 Water Traps, Plain Elbow, Tube Hang Respiratory Circuit, Adult, 72", Bi-Wye W/Temp Port, 2 Water Traps, Plain Elbow, Tube Hanger, Cap, 22mm Adapter
Catalog Number
-
Brand Name
72: Adult Respiratory Circuit
Version/Model Number
9289
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYH
Product Code Name
Drain, Tee (Water Trap)
Public Device Record Key
1140a0bd-8997-4fa0-8133-7349a9a29538
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
February 15, 2021
Package DI Number
10709078012577
Quantity per Package
20
Contains DI Package
00709078012570
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 |