| Primary Device ID | 05707480041954 |
| NIH Device Record Key | 670e93f5-9e20-43ac-87e3-26a62d30ef1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepmateThermocouple, Infant / Pediatric |
| Version Model Number | 814805-100 |
| Catalog Number | 814805-100 |
| 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 | 05707480041954 [Primary] |
| GS1 | 05707480096596 [Direct Marking] |
| BZQ | Monitor, breathing frequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-30 |
| Device Publish Date | 2016-09-21 |
| 05707480006359 - Head Wedge™ | 2024-07-04 Cervical Immobilization Device |
| 05707480006373 - Head Wedge™ | 2024-07-04 Cervical Immobilization Device |
| 05707480006380 - Military Head Wedge™ | 2024-07-04 Cervical Immobilization Device |
| 05707480021529 - Disposable Face Mask | 2024-06-05 Face mask |
| 05707480006205 - Disposable Face Mask | 2024-06-05 Face mask |
| 05707480021505 - Disposable Face Mask | 2024-06-05 Face mask |
| 05707480021499 - Disposable Face Mask | 2024-06-05 Face mask |
| 05707480021482 - Disposable Face Mask | 2024-06-05 Face mask |