Identity
- Trade Name
- ReDS Wearable System FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable System). FDA UDI
- Model / Reference
- V2.6 FDA UDI
- Description
- Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable System). FDA UDI
Identifiers
- Catalog Number
- SAS0120 FDA UDI
- Primary DI / UDI-DI
- 07290110070038 FDA UDI
- 510(k) Number
- K150095 FDA UDI
- FDA Product Code
- DSB FDA UDI
- GMDN Term
- Whole-body plethysmograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 FDA UDI
- Commercial Distribution
- Not 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
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 Conditional FDA UDI
ReDS Wearable System by Sensible Medical Innovations Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sensible Medical Innovations Ltd
Sources (1)
- FDA UDI c758ac3c-d613-44ad-969d-00878b6ff335 37 fields · synced May 30, 2026