| Primary Device ID | 20686864049627 |
| NIH Device Record Key | a10ffabb-42ee-4b8d-93f1-aad8666b6c3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMD-RITMED PREMIUM |
| Version Model Number | 8029 |
| Catalog Number | 8029 |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 50 |
| 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 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Cool dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864049623 [Unit of Use] |
| GS1 | 20686864049627 [Primary] |
| 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 | 2019-02-18 |
| Device Publish Date | 2019-01-17 |
| 20686864049627 | AMD-RITMED THUMBLOOP ISOLATION GOWN 3X-Large |
| 20686864059039 | AMD-RITMED PREMIUM NITRILE EXAMINATION GLOVES Blue Powder-Free Large |
| 20686864052337 | AMD-RITMED PREMIUM THUMBLOOP ISOLATION GOWN Regular |