Duns Number:009299017
Device Description: ULTIMIST HME/F&FLEX CONNECTOR
Catalog Number
AN-01217
Brand Name
ULTI-MIST™ HME/F ICUAND FLEX CONNECTOR
Version/Model Number
AN-01217
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
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
ae423951-2b9c-4745-9d59-606b4b0e5579
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
00612649141978
Quantity per Package
50
Contains DI Package
00612649199955
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 |