| Primary Device ID | 00686864056737 | 
| NIH Device Record Key | df349906-e2f6-4067-bc24-d10905ddd35c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MEDICOM SAFEMASK PREMIER | 
| Version Model Number | 2038 | 
| Catalog Number | 2038 | 
| 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 | 
| 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 | |
| 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 | |
| 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 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00686864056737 [Unit of Use] | 
| GS1 | 10686864056734 [Primary] | 
| GS1 | 20686864056731 [Package] Contains: 10686864056734 Package: OUTER CASE [10 Units] In Commercial Distribution | 
| OXZ | Pediatric/Child Facemask | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-11-09 | 
| Device Publish Date | 2020-10-30 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MEDICOM SAFEMASK PREMIER  90685653  not registered Live/Pending | AMD Medicom Inc. 2021-04-30 |