DEVICE: Medline (00080196778624)

Device Identifier (DI) Information

Medline
MED381
In Commercial Distribution
MED381
MEDLINE INDUSTRIES, INC.
00080196778624
GS1

10
025460908 *Terms of Use
MASK,FACE,CONE STYLE,BLUE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Antimicrobial 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 includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. 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.
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FDA Product Code

[?]
Product Code Product Code Name
MSH Respirator,surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020474 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b31fea5a-32f9-4d4c-90cd-0b7c205db2f3
July 06, 2018
3
October 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30080196778625 6 00080196778624 In Commercial Distribution
40080196778622 4 30080196778625 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 80080196778620 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-5463
service@medline.com
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