Duns Number:791140622
Device Description: Maxxi Rip X-Large inductive belt is a device intended to capture respiratory effort from a Maxxi Rip X-Large inductive belt is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies.
Catalog Number
SI1694
Brand Name
Neurovirtual
Version/Model Number
Maxxi RIP X-Large Inductive Belt
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
6626ec1a-0fb1-4b7f-81a4-2642bbbde7d8
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 |