DEVICE: MEDICOM CONFIDENCE (00686864058847)
Device Identifier (DI) Information
MEDICOM CONFIDENCE
212915
In Commercial Distribution
212915
AMD Medicom Inc
212915
In Commercial Distribution
212915
AMD Medicom Inc
EARLOOP FACE MASK - LEVEL 1 - BLUE
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? |
---|---|---|---|---|
66199 | Surgical/medical face mask, non-antimicrobial, single-use |
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. 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 |
---|
Storage Environment Temperature: less than 104 Degrees Fahrenheit |
Special Storage Condition, Specify: Avoid excessive heat |
Storage Environment Temperature: less than 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8c7e41d2-477f-4235-a1e8-5fc3ec4d13e6
December 22, 2023
3
November 11, 2021
December 22, 2023
3
November 11, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00686864058854 | 10 | 00686864058847 | 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:
00686864058991
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(514)636-6262
mdasilva@medicom.ca +1(514)636-6262
mkansou@medicom.ca
mdasilva@medicom.ca +1(514)636-6262
mkansou@medicom.ca