Centurion Medical Products Corp - CATHETERIZATION KIT - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CATHETERIZATION KIT

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More Product Details

Catalog Number

CC565

Brand Name

Centurion Medical Products Corp

Version/Model Number

CC565

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

-

Product Code Details

Product Code

KGZ

Product Code Name

ACCESSORIES, CATHETER

Device Record Status

Public Device Record Key

7fddbcb9-dbfa-47b4-a70d-375c0a28b7ef

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2021

Additional Identifiers

Package DI Number

40653160235133

Quantity per Package

12

Contains DI Package

10653160235132

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