| Primary Device ID | 05707480042500 |
| NIH Device Record Key | e8557f98-4a16-43b7-b2f1-8fd134297ad0 |
| Commercial Distribution Discontinuation | 2019-10-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SleepmateDC Low Impedance Kit |
| Version Model Number | 815710-100 |
| Catalog Number | 815710-100 |
| 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 | 05707480042500 [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 | 2019-10-11 |
| Device Publish Date | 2019-01-03 |
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