Duns Number:827445854
Device Description: The SNAP Model 8 is an at home sleep recorder with five data channels that records respira The SNAP Model 8 is an at home sleep recorder with five data channels that records respiratory and oximetry data. A nasal/oral cannula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position.
Catalog Number
-
Brand Name
Model 8
Version/Model Number
8-10000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
-
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
71ca3ada-2225-40b5-93b3-fa8cd0f50d39
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 18, 2017
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. | 2 |