Identity
- Trade Name
- ReDS System FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients. FDA UDI
- Model / Reference
- V2.6 FDA UDI
- Description
- Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients. FDA UDI
Identifiers
- Catalog Number
- GAS0045 FDA UDI
- Primary DI / UDI-DI
- 07290110070120 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
ReDS 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 6615a623-c5f8-4b03-b54e-2526ffa7e73b 38 fields · synced May 30, 2026