| Primary Device ID | B086202012 |
| NIH Device Record Key | 73c749d9-1225-460b-872b-e50bbdf4cbff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protect U Guard Bouffant Cap Blue |
| Version Model Number | P20201 |
| Company DUNS | 080070945 |
| Company Name | PROTECT U GUARD, LLC |
| Device Count | 1000 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B086202012 [Primary] |
| HIBCC | B08620210 [Unit of Use] |
| FYF | Cap, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-24 |
| B086205052 - Protect U Guard CPE Isolation Gown | 2021-02-10 Protect U Guard CPE Isolation Gown |
| B086291002 - Protect U Guard Hydrocolloid Sterile Dressing | 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 5x5cm |
| B086291012 - Protect U Guard Hydrocolloid Sterile Dressing | 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 10x10cm |
| B086291022 - Protect U Guard Hydrocolloid Sterile Dressing | 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Sacral 14x18cm |
| B086291032 - Protect U Guard Hydrocolloid Sterile Dressing | 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Oval/Heel 4x7cm |
| B086291042 - Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing | 2020-08-31 Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing 10x10cm |
| B086291102 - Protect U Guard Alginate Sterile Dressing | 2020-08-31 Protect U Guard Alginate Sterile Dressing 5x5cm |
| B086291112 - Protect U Guard Alginate Sterile Dressing | 2020-08-31 Protect U Guard Alginate Sterile Dressing 10x10cm |