Ambu® ACTion™ Fuser Pump - Action Fuser, 400 mL, 1-6 mL/hr Reg, 140 mm Cath, - Ambu A/S

Duns Number:305682023

Device Description: Action Fuser, 400 mL, 1-6 mL/hr Reg, 140 mm Cath, 6" Intro

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

418103400C

Brand Name

Ambu® ACTion™ Fuser Pump

Version/Model Number

418103400C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MEB

Product Code Name

Pump, infusion, elastomeric

Device Record Status

Public Device Record Key

e1d8dc13-7853-4971-964f-dc626c673638

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

05707480155910

Quantity per Package

5

Contains DI Package

05707480155927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AMBU A/S" Characteristics
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