| Primary Device ID | 00852231007675 |
| NIH Device Record Key | 71dac436-52f3-4812-9001-cc1271c2f299 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 36" x 83" Race Car Bed |
| Version Model Number | R2070 |
| Catalog Number | R2070 |
| Company DUNS | 021899778 |
| Company Name | HARD MANUFACTURING CO., 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | true |
| Phone | 716-893-1800 |
| kirsch@hardmfg.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852231007668 [Primary] |
| GS1 | 00852231007675 [Package] Contains: 00852231007668 Package: CRATE [1 Units] In Commercial Distribution |
| FNL | Bed, Ac-Powered Adjustable Hospital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |
| 00852231007019 - 36" x 83" Monroe Bed | 2018-03-29 |
| 00852231007033 - 36" x 83" Stockton Bed | 2018-03-29 |
| 00852231007057 - 36" x 72" Stockton Pan Bed | 2018-03-29 |
| 00852231007071 - 36" x 72" Monroe Pan Bed | 2018-03-29 |
| 00852231007095 - 36" x 72" Monroe Bed | 2018-03-29 |
| 00852231007118 - 36" x 72" Stockton Bed | 2018-03-29 |
| 00852231007132 - 36" x 72" Springfield Procedural Crib | 2018-03-29 |
| 00852231007156 - 36" x 72" Movesafe Crib | 2018-03-29 |