SmartInfuser Set, 5-15 ml/hr - Regulating Set 5-15, stand alone, complementary - Ambu A/S

Duns Number:305682023

Device Description: Regulating Set 5-15, stand alone, complementary accessory (to be used with ACTion Block an Regulating Set 5-15, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

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More Product Details

Catalog Number

-

Brand Name

SmartInfuser Set, 5-15 ml/hr

Version/Model Number

418000506

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"

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

39ded278-b2dd-4247-990d-09d2ddd2353a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 19, 2017

Additional Identifiers

Package DI Number

05707480119240

Quantity per Package

8

Contains DI Package

05707480119233

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