Medline Industries - TUBE, LEVIN, 12 FR, VINYL, 50", 50/CS - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: TUBE, LEVIN, 12 FR, VINYL, 50", 50/CS

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More Product Details

Catalog Number

DYND70482

Brand Name

Medline Industries

Version/Model Number

DYND70482

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

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Device Record Status

Public Device Record Key

80cf6bc0-fb5d-4b51-9ba1-e89c71a9b2cb

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Additional Identifiers

Package DI Number

40080196036296

Quantity per Package

50

Contains DI Package

10080196036295

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