Ambu® ACTion™ Block Pump - Action Block, 1000 mL (2 x 500 mL), 5-15 mL/hr - Ambu A/S

Duns Number:305682023

Device Description: Action Block, 1000 mL (2 x 500 mL), 5-15 mL/hr

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More Product Details

Catalog Number

419111000C

Brand Name

Ambu® ACTion™ Block Pump

Version/Model Number

419111000C

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

K072053,K072053

Product Code Details

Product Code

MEB

Product Code Name

Pump, infusion, elastomeric

Device Record Status

Public Device Record Key

d847bba3-404d-4676-a866-5fa0dd23ede8

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

05707480155859

Quantity per Package

5

Contains DI Package

05707480155866

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