| Primary Device ID | 05707480101849 |
| NIH Device Record Key | 8b0cd23f-3790-44da-93ea-d2a9449b45b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepmateThermocouple, PL |
| Version Model Number | 00103750 |
| Catalog Number | 00103750 |
| 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 | 05707480101849 [Primary] |
| BZQ | Monitor, breathing frequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
| 05707480006397 - Perfit Collar™ | 2026-01-30 Collar Perfit Infant size 1 |
| 05707480006403 - Perfit Collar™ | 2026-01-30 Collar Perfit Pediatric size 2 |
| 05707480006410 - Perfit Collar™ | 2026-01-30 Collar Perfit Neckless, size 3 |
| 05707480006427 - Perfit Collar™ | 2026-01-30 Collar Perfit short size 4 |
| 05707480006434 - Perfit Collar™ | 2026-01-30 Collar Perfit regular, size 5 |
| 05707480006441 - Perfit Collar™ | 2026-01-30 Collar Perfit tall size 6 |
| 05707480006458 - Perfit Collar™ | 2026-01-30 Collar Perfit Regular size 1 |
| 05707480006465 - Perfit Collar™ | 2026-01-30 Collar Perfit Pediatric, size 2, cases of 50 PCS |