| Primary Device ID | 08437011759023 |
| NIH Device Record Key | f7024693-602d-4712-baed-4842c8af9c7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nuubo System |
| Version Model Number | 2021 |
| Catalog Number | 2021 |
| Company DUNS | 475359621 |
| Company Name | SMART SOLUTIONS TECHNOLOGIES SL |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +34678078697 |
| pserna@nuubo.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437011759023 [Primary] |
| DSH | RECORDER, MAGNETIC TAPE, MEDICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2019-11-15 |
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| 08437011759023 | Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensing the patient� |
| 08437011759016 | Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’ |
| 08437011759078 | NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days. |