Duns Number:093772547
Device Description: ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, displ ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
Catalog Number
-
Brand Name
ANNE Sleep
Version/Model Number
SA-008
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"
Yes
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
K220095
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
a8884614-e794-4a3c-8bfe-2e023197989f
Public Version Date
July 28, 2022
Public Version Number
1
DI Record Publish Date
July 20, 2022
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 |