Duns Number:009299017
Device Description: ADULT ULTRA FLEX CIRCUIT PACK KIT
Catalog Number
F98004
Brand Name
ADULT ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT
Version/Model Number
F98004
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
2a10b10e-2c38-4ea4-8e89-019eb2305c61
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
August 30, 2018
Package DI Number
00612649213583
Quantity per Package
30
Contains DI Package
00612649213590
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 |