RITMED ASSURE WEAR VERSAGOWN A69956
GUDID 20686864041140
RITMED ASSUREWEAR VERSAGOWN FLEXNECK IMPERVIOUS - Over the head,Thumbloop, Blue X-Large
AMD Medicom Inc
Isolation gown, single-use| Primary Device ID | 20686864041140 |
| NIH Device Record Key | 17161f1c-f3b9-493f-9b29-16789ce86adf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RITMED ASSURE WEAR VERSAGOWN |
| Version Model Number | A69956 |
| Catalog Number | A69956 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 Dimensions
| 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 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864041146 [Unit of Use] |
| GS1 | 10686864041143 [Primary] |
| GS1 | 20686864041140 [Package] Contains: 10686864041143 Package: Outer Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190306
FDA Product Code
| FYC | Gown, Isolation, Surgical |
| OEA | Non-surgical isolation gown |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-21 |
| Device Publish Date | 2019-01-17 |
On-Brand Devices [RITMED ASSURE WEAR VERSAGOWN ]
| 10686864056215 | RITMED ASSURE WEAR VERSAGOWN FLEXNECK SMS Thumbloop Yellow Large |
| 20686864056434 | RITMED ASSURE WEAR VERSAGOWN FLEXNECK ISOLATION GOWN UNI |
| 20686864056427 | RITMED ASSURE WEAR VERSAGOWN FLEXNECK IMPERVIOUS OTH Blue UNI |
| 20686864041140 | RITMED ASSUREWEAR VERSAGOWN FLEXNECK IMPERVIOUS - Over the head,Thumbloop, Blue X-Large |
Trademark Results [RITMED ASSURE WEAR VERSAGOWN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RITMED ASSURE WEAR VERSAGOWN 90685683 not registered Live/Pending |
AMD Medicom Inc. 2021-04-30 |
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