Duns Number:475359621
Device Description: Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the pati Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
Catalog Number
2020
Brand Name
Nuubo System
Version/Model Number
2020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173461
Product Code
DSH
Product Code Name
RECORDER, MAGNETIC TAPE, MEDICAL
Public Device Record Key
90321852-9fe5-44c1-b63e-385a1b5684ad
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |