DEVICE: MEDICOM SAFEMASK N95 (10686864033766)

Device Identifier (DI) Information

MEDICOM SAFEMASK N95
M2321
Not in Commercial Distribution
M2321
AMD Medicom Inc
10686864033766
GS1
February 01, 2024
20
256880576 *Terms of Use
SAFEMASK N95 CONE RESPIRATOR EARLOOP WHITE
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57794 Surgical/medical respirator, non-antimicrobial, single-use
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
Active false
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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
Special Storage Condition, Specify: Cool dry place
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Clinically Relevant Size

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

11513bab-5f31-4dca-9d88-febf823fdadb
February 02, 2024
8
September 15, 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
20686864033763 8 10686864033766 2024-02-01 Not in Commercial Distribution OUTER CASE
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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: 00686864033769 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(514)636-6262 2309
mkansou@medicom.ca
+1(514)636-6262
mdasilva@medicom.ca
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