ASP MEDICAL - MASK, FACE, W/ EXTENDED SHIELD, BLUE, EARLOOPS, - Asp Global, LLC

Duns Number:080361159

Device Description: MASK, FACE, W/ EXTENDED SHIELD, BLUE, EARLOOPS, TESTED TO ASTM F1862 (FLUID PROTECTION BAR MASK, FACE, W/ EXTENDED SHIELD, BLUE, EARLOOPS, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER) LEVEL 3

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More Product Details

Catalog Number

-

Brand Name

ASP MEDICAL

Version/Model Number

FMT630V

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182515,K182515,K182515

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

5d84a7ab-0df5-4fc1-871b-56153890052d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 21, 2020

Additional Identifiers

Package DI Number

10840216108735

Quantity per Package

25

Contains DI Package

00840216108738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX

"ASP GLOBAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1046
2 A medical device with a moderate to high risk that requires special controls. 23
U Unclassified 2