Duns Number:305682023
Device Description: Action Fuser, 650 mL, 5-15 mL/hr Reg, 140 mm Cath, 6" Intro
Catalog Number
418104650M
Brand Name
Ambu® ACTion™ Fuser Pump
Version/Model Number
418104650M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K061409,K061409
Product Code
MEB
Product Code Name
Pump, infusion, elastomeric
Public Device Record Key
3b831c05-b48b-4a4b-b140-ac6332772e77
Public Version Date
February 11, 2022
Public Version Number
1
DI Record Publish Date
February 03, 2022
Package DI Number
05707480156092
Quantity per Package
5
Contains DI Package
05707480156108
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |