DEVICE: MEDICOM SAFEMASK (10686864010248)
Device Identifier (DI) Information
MEDICOM SAFEMASK
2021
Not in Commercial Distribution
2021
AMD Medicom Inc
2021
Not in Commercial Distribution
2021
AMD Medicom Inc
SAFEMASK CONE ALUMINIUM NOSE PINK
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 |
---|---|
FXX | Mask, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Cool dry place |
Storage Environment Temperature: less than 40 Degrees Celsius |
Storage Environment Temperature: less than 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9e81c0d8-1682-4da0-8ced-056c7c6904a1
February 02, 2024
7
September 15, 2016
February 02, 2024
7
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 |
---|---|---|---|---|---|
20686864010245 | 12 | 10686864010248 | 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:
00686864010241
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(514)636-6262
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca
mkansou@medicom.ca +1(514)636-6262
mdasilva@medicom.ca