| Primary Device ID | B086291502 |
| NIH Device Record Key | a934b133-81d7-445e-a332-2521b974edbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protect U Guard U-Shaped IV Transparent Dressing |
| Version Model Number | P19150 |
| Company DUNS | 080070945 |
| Company Name | PROTECT U GUARD, LLC |
| Device Count | 100 |
| 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 |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Width | 6 Centimeter |
| Length | 7 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B086091500 [Unit of Use] |
| HIBCC | B086191501 [Primary] |
| HIBCC | B086291502 [Package] Contains: B086191501 Package: CARTON [2400 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-31 |
| Device Publish Date | 2020-08-21 |
| 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 |