Medline Industries, Inc. - ANGIOGRAPHY PACK - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: ANGIOGRAPHY PACK

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More Product Details

Catalog Number

DYNJV0173I

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJV0173I

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

OEQ

Product Code Name

Angiography/angioplasty kit

Device Record Status

Public Device Record Key

4ade6a08-a592-4005-8e90-27214368403d

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

August 28, 2018

Additional Identifiers

Package DI Number

40889942965022

Quantity per Package

6

Contains DI Package

10889942965021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7