Duns Number:791140622
Device Description: Maxxi Rip System length: 7ft is a device intended to capture respiratory effort from a pat Maxxi Rip System length: 7ft is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies.
Catalog Number
SI1669
Brand Name
Neurovirtual
Version/Model Number
Maxxi RIP System Length: 7ft
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171304
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
7482b317-e9b1-467d-afd5-87577ccd92e8
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 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. | 38 |