| Primary Device ID | 20810132044360 |
| NIH Device Record Key | 30579ad3-1285-4779-8633-8dcdb35a3ffe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HCS Sourcing |
| Version Model Number | 3004OTCB2XL |
| Company DUNS | 080220245 |
| Company Name | Concordance Healthcare Solutions LLC |
| Device Count | 10 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810132044366 [Primary] |
| GS1 | 20810132044360 [Unit of Use] |
| OEA | Non-Surgical 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 | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| 10810132044325 | WEDGE FOR HEEL PROTECTOR |
| 10810132044318 | PROTECTOR HEEL PREMIUM OPEN FOOT |
| 00810132044304 | HEEL PROTECTOR STANDARD |
| 10810132044295 | PROTECTOR HEEL CONVOLUTED FOAM |
| 20810132044285 | COTTON BALL LARGE STERILE 100% COTTON |
| 10810132044202 | SHARPS CONTAINER 8G RED |
| 10810132044196 | SHARPS CONTAINER 12QT/3G CLEAR |
| 10810132044189 | 710008QR |
| 10810132044172 | SHARPS CONTAINER 5.4QT CLEAR |
| 10810132044165 | SHARPS CONTAINER 5.4QT RED |
| 00810132044151 | SHARPS CONTAINER 5QT RED |
| 00810132044144 | SHARPS CONTAINER, 1QT RED HINGED ENTRY |
| 20810132044360 | Gown, Isolation XL, AAMI Rated Level 2, Yellow. SMS Material, Over the Head Neck, Waist Tie and |