Identity
- Trade Name
- ANNE Sleep FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SA-008 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860004541714 FDA UDI
- 510(k) Number
- K220095 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
ANNE Sleep by Sibel Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple physiological parameter recorder, reusable.
- BioButton At-Home Kit — BIOINTELLISENSE, INC. · Class II
- circul pro, x-large — Bodimetrics, LLC · Class II
- SansaTM — Huxley Medical · Class II
- AcuPebble — Acurable Limited · Class II
- Wearable Patch — ATLAS LIFT TECH, INC. · Class I
- BioButton (Reprocessed, NF Version) — BIOINTELLISENSE, INC. · Class II
- SOMNOwatch plus ACTI — Somnomedics GmbH · Class II
- PLM Sensor Set — Somnomedics GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sibel Health Inc.
Sources (1)
- FDA UDI a8884614-e794-4a3c-8bfe-2e023197989f 34 fields · synced Jun 1, 2026