Medline - MASK, FACE, YELLOW ISOLATION,FOLDED BULK - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: MASK, FACE, YELLOW ISOLATION,FOLDED BULK

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More Product Details

Catalog Number

NON28300

Brand Name

Medline

Version/Model Number

NON28300

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FXX

Product Code Name

Mask, surgical

Device Record Status

Public Device Record Key

198f00ec-d1c6-4ff1-ac43-f8de04809434

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Additional Identifiers

Package DI Number

40080196362265

Quantity per Package

1000

Contains DI Package

10080196362264

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