| Primary Device ID | 00613732114046 |
| NIH Device Record Key | 3a7d9c59-1f42-4fa3-afa4-677eb8be08e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROHO LOW PROFILE Single Compartment Cushion |
| Version Model Number | 1R1211LPC |
| Company DUNS | 006614792 |
| Company Name | Roho, 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 | 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 | 00613732114046 [Primary] |
| KIC | Cushion, Flotation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-15 |
| 00613732005610 | 1R1110LPC |
| 00613732084561 | 1R1310LPC |
| 00613732053840 | 1R1210LPC |
| 00613732053826 | 1R1111LPC |
| 00613732006716 | 1R99LPC |
| 00613732006617 | 1R98LPC |
| 00613732006556 | 1R911LPC |
| 00613732006488 | 1R910LPC |
| 00613732006372 | 1R89LPC |
| 00613732006266 | 1R88LPC |
| 00613732006167 | 1R87LPC |
| 00613732006105 | 1R810LPC |
| 00613732006020 | 1R79LPC |
| 00613732005955 | 1R78LPC |
| 00613732005863 | 1R77LPC |
| 00613732005788 | 1R67LPC |
| 00613732005726 | 1R66LPC |
| 00613732005689 | 1R119LPC |
| 00613732005535 | 1R109LPC |
| 00613732005436 | 1R108LPC |
| 00613732005368 | 1R1011LPC |
| 00613732005290 | 1R1010LPC |
| 00613732005153 | 1RSMLPC |
| 00613732005054 | 1RLGLPC |
| 00613732114084 | 1R129LPC |
| 00613732114060 | 1R1212LPC |
| 00613732114046 | 1R1211LPC |
| 00613732114022 | 1R1311LPC |