| Primary Device ID | 00815027011935 |
| NIH Device Record Key | 864db717-1182-4fa0-be52-798db2709e0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DALTON XCELL AIR MATTRESS 5000 |
| Version Model Number | PM-XCELL5000 |
| Company DUNS | 874709348 |
| Company Name | DALTON MEDICAL CORPORATION |
| 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 | true |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815027011935 [Primary] |
| FNM | Mattress, Air Flotation, Alternating Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2018-06-12 |
| 00815027012703 - DALTON TRANSFER BENCH | 2025-09-26 SLIDING TRANSFER BENCH |
| 00815027012741 - DALTON QUAD CANE | 2025-09-26 QUAD CANE BLACK SMALL BASE |
| 00815027012758 - DALTON TRANSFER BENCH | 2025-09-26 TRANSFER BENCH NON PADDED 500 LBS |
| 00815027012765 - DALTON SHOWER BENCH | 2025-09-26 SHOWER BENCH WITH BACK AND ARM |
| 00815027012772 - DALTON YOUTH WALKER | 2025-09-26 YOUTH WALKER WITH WHEEL, FOLDING |
| 00815027012789 - DALTON WALKER | 2025-09-26 WALKER WITH WHEEL, FOLDING |
| 00815027012796 - DALTON WALKER | 2025-09-26 WALKER HEMI |
| 00815027012819 - DALTON WALKER PLATFORM | 2025-09-26 WALKER FOREARM ATTACHMENT |