MEDICOM SAFEMASK PREMIER 2018
GUDID 20686864027045
SAFEMASK PREMIER EARLOOP TEAL
AMD Medicom Inc
Surgical/medical face mask, single-use| Primary Device ID | 20686864027045 |
| NIH Device Record Key | 7defc456-665f-41ea-b5f1-c773282820e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDICOM SAFEMASK PREMIER |
| Version Model Number | 2018 |
| Catalog Number | 2018 |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864027041 [Unit of Use] |
| GS1 | 10686864027048 [Primary] |
| GS1 | 20686864027045 [Package] Contains: 10686864027048 Package: OUTER CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051291
FDA Product Code
| FXX | Mask, surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [MEDICOM SAFEMASK PREMIER]
| 20686864109086 | SAFEMASK PREMIER ELITE EARLOOP PINK |
| 20686864045155 | SAFEMASK PREMIER EARLOOP WHITE |
| 10686864040764 | MEDICOM SAFEMASK PREMIER SAMPLE PACK |
| 20686864027113 | SAFEMASK PREMIER PLUS EARLOOP BLUE |
| 20686864027052 | SAFEMASK PREMIER ELITE EARLOOP BLUE |
| 20686864027045 | SAFEMASK PREMIER EARLOOP TEAL |
| 20686864024518 | SAFEMASK PREMIER EARLOOP PINK |
| 20686864023399 | SAFEMASK PREMIER EARLOOP LAVENDER |
| 20686864011020 | SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP TEAL |
| 20686864008365 | SAFEMASK PREMIER EARLOOP YELLOW |
| 20686864002950 | SAFEMASK PREMIER EARLOOP BLUE |
| 00686864057000 | SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP BLEU L3 |
| 00686864056737 | SAFEMASK PREMIER Pediatric Procedure Masks Earloop L1/Recommended age: 4 -12 |
| 00686864057017 | SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP PINK L3 |
Trademark Results [MEDICOM SAFEMASK PREMIER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDICOM SAFEMASK PREMIER 90685653 not registered Live/Pending |
AMD Medicom Inc. 2021-04-30 |
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