FDA UDI
In Commercial Distribution
🇺🇸 United States
Nuubo System
DI: 08437011759092
·
Model: 1935
·
SMART SOLUTIONS TECHNOLOGIES SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nuubo System
- Primary DI
- 08437011759092
- Version / Model
- 1935
- Catalog Number
- 1935
- Company Name
- SMART SOLUTIONS TECHNOLOGIES SL
- Labeler DUNS
- 475359621
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-20
- Public Version
- 1
- Public Version Date
- 2019-11-28
- Public Version Status
- New
- Public Device Record Key
- b55d5abd-e33c-4cd7-be38-a509a285f411
Device Description
Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, diagnostic, programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41651 | Electrocardiographic long-term ambulatory recording analyser application software | A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437011759092 | GS1 |
Customer Contacts
- Phone
- +34678078697
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173461 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 45 Degrees Celsius