| Primary Device ID | 10813360023407 |
| NIH Device Record Key | d5bff4aa-8a2e-4e39-ad5f-0a6dade41e97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protexter |
| Version Model Number | ICP-8150 |
| Catalog Number | ICP-8150 |
| Company DUNS | 078780963 |
| Company Name | ICP MEDICAL, LLC |
| Device Count | 1 |
| 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 | 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 | 00813360023400 [Primary] |
| GS1 | 10813360023407 [Package] Contains: 00813360023400 Package: Bag [10 Units] In Commercial Distribution |
| GS1 | 20813360023404 [Package] Package: Case [10 Units] In Commercial Distribution |
| 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 | 2022-11-17 |
| Device Publish Date | 2022-11-09 |
| 10813360021526 | Universal Comfort Gown |
| 10813360021649 | Universal Comfort Gown |
| 10813360021564 | Universal Extended Wear Gown |
| 10813360021670 | Full Coverage |
| 10813360021663 | Universal Comfort Gown |
| 10813360021656 | Universal Comfort Gown |
| 10813360021595 | Universal Isolation Gown |
| 10813360022059 | Isolation Gown |
| 10813360023407 | Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, Universal |
| 00068162000511 | Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elasti |