Identity
- Trade Name
- Model 8 FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 8-10000 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B577810000 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnograph 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
Model 8 by Snap Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Snap Diagnostics, LLC
Sources (1)
- FDA UDI 71ca3ada-2225-40b5-93b3-fa8cd0f50d39 33 fields · synced May 30, 2026