| Primary Device ID | 00810006680898 |
| NIH Device Record Key | 78e36f9c-260f-414e-bff2-f04c0efbdd01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guardian Heel Protector |
| Version Model Number | HP201Y |
| Catalog Number | HP201Y |
| Company DUNS | 958758146 |
| Company Name | PRIMO INC |
| 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810006680508 [Primary] |
| GS1 | 00810006680898 [Package] Contains: 00810006680508 Package: CASE [12 Units] In Commercial Distribution |
| FMP | Protector, Skin Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-20 |
| 00810006683134 | Guardian Heel Protector, Black/Sheepskin |
| 00810006683127 | Guardian PREEMIE Heel Protector, Purple/Navy |
| 00810006683110 | Guardian Heel Protector, Purple/Navy |
| 00810006680898 | Guardian FALL RISK Heel Protector, Yellow |
| 00810006680881 | Guardian Heel Protector, Navy/Gray |
| 00810006680874 | Guardian Heel Protector, Black/Khaki |