| Primary Device ID | 01634916803883 |
| NIH Device Record Key | 0e746ab1-86c3-4043-8dff-546f9465b1c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComPel Isolation Gown |
| Version Model Number | 661Y4994 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 48 |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916803884 [Primary] |
| GS1 | 01634916803883 [Unit of Use] |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
[01634916803883]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-21 |
| Device Publish Date | 2021-06-11 |
| 01634916814520 | EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck |
| 01634916803883 | Isolation Gown, ComPel with Carbon, AAMI Level 2, Tie Closures Neck and Waist, Raglan Sleeves wi |
| 01634916800721 | EasyRelease Isolation Gown, Compel with Carbon, AAMI Level 2, Bound Neck, Velcro Hook & Loop Clo |
| 10634916822158 | ComPel Isolation Gown, AAMI Level 2, 100% Polyester, Yellow, Tie Closures Neck and Waist, Raglan |
| 00634916501681 | ComPel Isolation Gown, AAMI Level 2, Yellow, 5XL, 100% Polyester, Plastic Snap Closure Neck, Col |
| 00634916501674 | ComPel Isolation Gown, AAMI Level 2, Yellow, 3XL, 100% Polyester, Plastic Snap Closure Neck, Col |
| 00634916501667 | ComPel Isolation Gown, AAMI Level 2, Yellow, XL, 100% Polyester, Plastic Snap Closure Neck, Colo |
| 00634916857535 | Isolation Gown, ComPel, Yellow, Raglan Sleeves, Metal Snaps at Neck and Waist, Elastic Sleeve |