ACTion Block Pump, 650ml, Dual 1-6 ml/hr - ACTion Block 650 ml, 1-6 ml/hr, Dual Reg. Set - Ambu A/S

Duns Number:305682023

Device Description: ACTion Block 650 ml, 1-6 ml/hr, Dual Reg. Set

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More Product Details

Catalog Number

419110650

Brand Name

ACTion Block Pump, 650ml, Dual 1-6 ml/hr

Version/Model Number

419110650

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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

6559286a-2dc1-41fe-b85d-9faa6d3f6a08

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

05707480120864

Quantity per Package

4

Contains DI Package

05707480120857

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