FDA UDI
In Commercial Distribution
🇺🇸 United States
Nuubo System
DI: 08437011759016
·
Model: 2020
·
SMART SOLUTIONS TECHNOLOGIES SL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nuubo System
- Primary DI
- 08437011759016
- Version / Model
- 2020
- Catalog Number
- 2020
- Company Name
- SMART SOLUTIONS TECHNOLOGIES SL
- Labeler DUNS
- 475359621
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-15
- Public Version
- 1
- Public Version Date
- 2019-11-25
- Public Version Status
- New
- Public Device Record Key
- 90321852-9fe5-44c1-b63e-385a1b5684ad
Device Description
Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSH | RECORDER, MAGNETIC TAPE, MEDICAL | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61821 | Electrocardiographic lead set, single-use | A collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437011759016 | 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