Medline - SET,IV ADMIN,125",2 NDL-FREE Y-SITES, 15 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: SET,IV ADMIN,125",2 NDL-FREE Y-SITES, 15

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More Product Details

Catalog Number

DYTC1307763

Brand Name

Medline

Version/Model Number

DYTC1307763

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

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

345ea3f6-8eea-426c-a941-97441947ee45

Public Version Date

November 29, 2021

Public Version Number

4

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

40884389811857

Quantity per Package

50

Contains DI Package

10884389811856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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