| Primary Device ID | 20813360023046 |
| NIH Device Record Key | 796d0eed-c96f-48d6-999e-e8216e8fc6e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Full Coverage Isolation Gown #RR-300FC |
| Version Model Number | 1 |
| Company DUNS | 078780963 |
| Company Name | ICP MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813360023042 [Primary] |
| GS1 | 10813360023049 [Package] Contains: 00813360023042 Package: Bag [10 Units] In Commercial Distribution |
| GS1 | 20813360023046 [Package] Contains: 10813360023049 Package: Case [10 Units] In Commercial Distribution |
| FYC | Gown, Isolation, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-04 |
| 10688162000020 - Protexer | 2025-08-27 Fluid Resistant Shoe Cover, Traction Coating, Blue, Large |
| 10813360021519 - Protexer | 2025-08-27 Bouffant Cap, Blue, 23" |
| 10813360021786 - Protexer | 2025-08-27 Fluid Resistant Shoe Cover, Traction Coating, Universal |
| 10813360021793 - Protexer | 2025-08-27 Fluid Resistant Shoe Cover, Traction Coating, Extra Large |
| 10813360021472 - Protexer | 2025-08-25 Lab Coat, Blue, Traditional Collar, Knit Cuffs, Snap Front, 3 pockets, 2XL |
| 10688162000518 - Protexter | 2025-08-20 Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, 2XL |
| 00688162000030 - Protexer | 2025-08-18 Scrub Bottom, SMS, Blue, Elastic Waist, Large |
| 00688162290004 - Protexer | 2025-08-18 Scrub Top, SMS, Blue, V-Neck, Large |