Medline Industries, Inc. - BASIC ADMIT KIT - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: BASIC ADMIT KIT

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More Product Details

Catalog Number

P198174

Brand Name

Medline Industries, Inc.

Version/Model Number

P198174

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

0f9c2eed-1a59-4d6f-979f-b761e8c599b7

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

40889942021575

Quantity per Package

12

Contains DI Package

10889942021574

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