MEDLINE - IV START KIT - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: IV START KIT

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More Product Details

Catalog Number

DYNDG74273

Brand Name

MEDLINE

Version/Model Number

DYNDG74273

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRS

Product Code Name

I.V. start kit

Device Record Status

Public Device Record Key

1889f3d3-cdc9-4094-906a-09c623b9864c

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Additional Identifiers

Package DI Number

40888277056139

Quantity per Package

100

Contains DI Package

10888277056138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CENTURION MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6043
2 A medical device with a moderate to high risk that requires special controls. 4077
U Unclassified 1