| Primary Device ID | 00616784046624 |
| NIH Device Record Key | 2ff97e54-03d1-418b-95b9-9506e7d46f7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bariatric Homecare Bed Rail |
| Version Model Number | 10466 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 2 |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784046617 [Unit of Use] |
| GS1 | 00616784046624 [Primary] |
| FNL | Bed, Ac-Powered Adjustable Hospital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-19 |
| Device Publish Date | 2018-05-19 |
| 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 |
| 00840117348790 - Flavored Oral Swab, For Professional And Hospital use | 2026-01-29 Individually Wrapped |
| 00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use | 2026-01-29 Individually Wrapped |
| 00840117348837 - Oral Swabsticks, Flavored w/Dentrifice | 2026-01-29 |
| 00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use | 2026-01-29 |
| 00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal | 2026-01-13 |