| Primary Device ID | 00840117341050 |
| NIH Device Record Key | 40b44670-fedd-40f1-9429-b0299b16c5f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CozyTherm Heat Relief Wrap, Back |
| Version Model Number | 1457 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117340992 [Package] Contains: 00840117341029 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 00840117341029 [Package] Package: Box [3 Units] In Commercial Distribution |
| GS1 | 00840117341050 [Primary] |
| OMW | Adhesive Backed Thermal Skin Patches |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-21 |
| Device Publish Date | 2025-02-13 |
| 00810180843249 - Disposable Coveralls | 2026-02-24 Disposable Coveralls, Universal Size, White |
| 00810180843126 - Shoe Cover | 2026-02-23 Shoe Cover- Universal Size, Non-Conductive, 150 Pairs |
| 00810180843133 - Shoe Cover | 2026-02-23 Shoe Cover- Universal Size, Non-Conductive, Non-Skid, 150 Pairs |
| 00810180843140 - Shoe Cover | 2026-02-23 Shoe Cover, Non-Conductive and Non-Skid, XL |
| 00810180843164 - Disposable BP Cuff Barrier Sleeves | 2026-02-23 Disposable BP Cuff Barrier Sleeves, Non-Woven, White, Universal |
| 00810180842716 - Electrode Skin Prep Pads | 2026-02-17 |
| 00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g | 2026-02-04 |
| 00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet | 2026-02-03 |