| Primary Device ID | 00195893164608 |
| NIH Device Record Key | 1e6efecf-4078-4eae-9874-44236a9601a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AXILLARY POSITIONING ROLL |
| Version Model Number | AXR-2000 |
| Company DUNS | 079575412 |
| Company Name | Infinitus Medical Technologies LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00195893164608 [Primary] |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-04 |
| Device Publish Date | 2025-07-25 |
| 00195893164608 - AXILLARY POSITIONING ROLL | 2025-08-04 |
| 00195893164608 - AXILLARY POSITIONING ROLL | 2025-08-04 |
| 00195893397556 - AZUL, ITPW | 2025-08-04 |
| 00860006375959 - LUNA SUPINE PAD SYSTEM | 2025-08-04 |
| 00860006375966 - KIT, CHEST PAD AND STRAP | 2025-08-04 |
| 00195893257713 - GENESIS BI-WING AAP | 2024-07-25 |
| 00195893509492 - VISIWRAP SURGICAL FACE PROTECTOR | 2024-07-25 |
| 00860003986868 - GENESIS BI-WING AAP, XL | 2024-07-25 |
| 00860003986875 - HADRON FPLS INFINITY | 2024-07-25 |