| Primary Device ID | 20686864053631 |
| NIH Device Record Key | 66b87fb5-0737-41d5-a412-8d0ec8e5fe40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMD-RITMED DISTECH |
| Version Model Number | D-8009 |
| Catalog Number | D-8009 |
| 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 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com |
| 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 | 00686864053637 [Unit of Use] |
| GS1 | 10686864053634 [Primary] |
| GS1 | 20686864053631 [Package] Contains: 10686864053634 Package: Outer Case [5 Units] Discontinued: 2023-06-12 Not in Commercial Distribution |
| OEA | Non-surgical isolation gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-13 |
| Device Publish Date | 2019-01-17 |
| 20686864034661 | DISTECH FACEMASK EARLOOP YELLOW |
| 20686864034654 | DISTECH FACEMASK EARLOOP YELLOW |
| 20686864034647 | DISTECH FACEMASK EARLOOP BLUE |
| 20686864034135 | DISTECH SMALL MASK EARLOOP WHITE |
| 20686864028608 | DISTECH FACEMASK EARLOOP GREEN |
| 20686864028592 | DISTECH FACEMASK EARLOOP YELLOW |
| 20686864028585 | DISTECH FACEMASK EARLOOP PINK |
| 20686864028578 | DISTECH FACEMASK EARLOOP BLUE |
| 20686864053594 | AMD-RITMED DISTECH KRIMPED GAUZE ROLL 4 1/2 Inch X 4.1 Yard |
| 20686864053655 | AMD-RITMED DISTECH ISOLATION GOWN X-Large |
| 20686864053631 | AMD-RITMED DISTECH ISOLATION GOWN Medium/Large |