AccessGUDID - DEVICE: Medline (00080196311869)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MEDN95
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEDN95
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 00080196311869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: MASK,RESPIRATOR,N95,CONE STYLE,LF

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Surgical respirator	A non-sterile filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the worker and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Surgical respirator

A non-sterile filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the worker and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
MSH	Respirator,surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020474	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b5e421b-1c06-4554-83ae-89777c2f5337
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 14, 2016