| Primary Device ID | 20686864060677 |
| NIH Device Record Key | 77b56fa6-ea4c-47e1-8783-385ae0975e13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RITMED ASSUREWEAR |
| Version Model Number | A69978-X |
| Catalog Number | A69978-X |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864060673 [Unit of Use] |
| GS1 | 10686864060670 [Primary] |
| GS1 | 20686864060677 [Package] Contains: 10686864060670 Package: Outer Case [10 Units] In Commercial Distribution |
| OEA | Non-surgical isolation gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-08 |
| Device Publish Date | 2023-11-30 |
| 00686864056997 | RITMED ASSUREWEAR IMPERVIOUS Level 2 Neck ties & Knit cuffs - Yellow - Large |
| 00686864057826 | RITMED ASSUREWEAR Isolation Gown Level 2 Over-the-head, Yellow, X-Large |
| 20686864060677 | Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - X-Large |
| 20686864060660 | Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - Large |
| 20686864057813 | Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - Large |