| Primary Device ID | 00810006680867 |
| NIH Device Record Key | f054359e-d02e-4c92-b722-1a2d6944d0b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeelCheck |
| Version Model Number | HCB |
| Catalog Number | HCB |
| 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 | 00810006680478 [Primary] |
| GS1 | 00810006680867 [Package] Contains: 00810006680478 Package: CASE [10 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 |
| 10810006681557 | HeelCheck- Small (w/wedge) |
| 00810006680867 | HeelCheck - Bariatric |
| 10810006680147 | HeelCheck - Small |
| 10810006680130 | HeelCheck - Bariatric (w/wedge) |
| 10810006680123 | HeelCheck - Standard (w/wedge) |
| 10810006680116 | HeelCheck - Standard |