MINNIE - Minnie V2 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Minnie V2

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More Product Details

Catalog Number

5711

Brand Name

MINNIE

Version/Model Number

IPN039087

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

-

Product Code Details

Product Code

DQY

Product Code Name

Catheter, percutaneous

Device Record Status

Public Device Record Key

b001a932-6048-48e3-bac5-a7a02b4f1243

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 02, 2020

Additional Identifiers

Package DI Number

20841156103405

Quantity per Package

5

Contains DI Package

10841156103408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26