Duns Number:009299017
Device Description: ADULT ANESTHESIA CIRCUIT
Catalog Number
QGH8603-6121Z
Brand Name
ADULT ANESTHESIABREATHING CIRCUIT
Version/Model Number
QGH8603-6121Z
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
1953b51e-13c6-4e58-ad07-cdc1bccf8aa7
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
December 20, 2017
Package DI Number
00612649213217
Quantity per Package
30
Contains DI Package
00612649213224
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 | 717 |
2 | A medical device with a moderate to high risk that requires special controls. | 41 |