| Primary Device ID | 00850520008044 |
| NIH Device Record Key | 1bc8da81-1f27-4982-9451-b0e3358b22e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STAGE IV, LOW AIR LOSS, L/P |
| Version Model Number | ASM200111 |
| Company DUNS | 079220324 |
| Company Name | KREG MEDICAL 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 | true |
| 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 | false |
| Phone | (866) 760-5734 |
| kmiudiInfo@kreg.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850520008044 [Primary] |
| IKY | Mattress, Flotation Therapy, Non-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
| 00850520008280 - AP MAX MATTRESS SYSTEM | 2023-10-24 Hospital Bed Surface |
| 00850520008006 - SINGLE ARM TRAPEZE ASSEMBLY | 2018-10-22 Single Arm Trapeze |
| 00850520008020 - CATALYST BARIATRIC BED | 2018-10-22 Hospital Bariatric Bed with Standing Frame and Drive |
| 00850520008037 - THE KREG INTEGRATED CLRT MATTRESS SYSTEM | 2018-10-22 Hospital Bed Surface |
| 00850520008044 - STAGE IV, LOW AIR LOSS, L/P | 2018-10-22Hospital Bed Surface |
| 00850520008044 - STAGE IV, LOW AIR LOSS, L/P | 2018-10-22 Hospital Bed Surface |
| 00850520008051 - EZ WIDER BARIATRIC BED | 2018-10-22 Hospital Bariatric Bed |
| 00850520008068 - EZ WIDER BARIATRIC BED | 2018-10-22 Hospital Bariatric Bed |
| 00850520008075 - EZ WIDER BARIATRIC BED | 2018-10-22 Hospital Bariatric Bed with Drive |