| Primary Device ID | 05707480042555 |
| NIH Device Record Key | abb4d4c0-da33-49b2-be35-b1315902897c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepmateAC Body Position Sensor |
| Version Model Number | 815600-000 |
| Catalog Number | 815600-000 |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480042555 [Primary] |
| LXJ | System, optical position/movement recording |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-04 |
| Device Publish Date | 2019-01-03 |
| 05707480157136 - Ambu® aScope™ Duodeno 2 | 2024-07-29 Duodenoscope |
| 05707480006540 - Immobilization Kit, with | 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult |
| 05707480006557 - Immobilization Kit, with | 2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric |
| 05707480037308 - Immobilization Kit, with | 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult |
| 05707480038626 - Immobilization Kit, with | 2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult |
| 05707480006601 - Silicone Face Mask | 2024-07-16 Reusable face mask |
| 05707480006625 - Silicone Face Mask | 2024-07-16 Reusable face mask |
| 05707480006632 - Silicone Face Mask | 2024-07-16 Reusable face mask |