DEVICE: MEDICOM SAFEMASK N95 (10686864033766)
Device Identifier (DI) Information
MEDICOM SAFEMASK N95
M2321
Not in Commercial Distribution
M2321
AMD Medicom Inc
M2321
Not in Commercial Distribution
M2321
AMD Medicom Inc
SAFEMASK N95 CONE RESPIRATOR EARLOOP WHITE
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MSH | Respirator,surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020474 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Cool dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
11513bab-5f31-4dca-9d88-febf823fdadb
February 02, 2024
8
September 15, 2016
February 02, 2024
8
September 15, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00686864033769
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(514)636-6262
2309
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca