LHM - Fluid Resistant Procedure Mask- Flat Pleated, Ear - LHM MEDICAL TECHNOLOGY (HONG KONG) LIMITED

Duns Number:687103537

Device Description: Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Green. The Fluid Re Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, Green. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

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More Product Details

Catalog Number

-

Brand Name

LHM

Version/Model Number

LHM-E1303

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

3bab6339-debd-485b-9071-d5e7265330ba

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Additional Identifiers

Package DI Number

14897112130038

Quantity per Package

10

Contains DI Package

04897112130031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case