Medtronic Extended - Single use infusion set for subcutaneous - Unomedical A/S

Duns Number:306032491

Device Description: Single use infusion set for subcutaneous infusion. The infusion set must be used as descri Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

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More Product Details

Catalog Number

-

Brand Name

Medtronic Extended

Version/Model Number

MMT-440AH

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

K210544,K210544,K210544

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

a53a4b7d-9e0b-4993-9a32-276c56471018

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Additional Identifiers

Package DI Number

05705244023260

Quantity per Package

60

Contains DI Package

05705244023253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box

"UNOMEDICAL A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14