Identity
- Trade Name
- ReDS Pro System FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting FDA UDI
- Model / Reference
- V2.7 FDA UDI
- Description
- Fluid status monitor This catalog item is used by a health care provider in the hospital, hospital like facilities and home setting FDA UDI
Identifiers
- Catalog Number
- GAS0046-R FDA UDI
- Primary DI / UDI-DI
- 07290110070267 FDA UDI
- 510(k) Number
- K180479 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 Unsafe FDA UDI
ReDS Pro System by Sensible Medical Innovations Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 736d76d6-ae09-4ce9-8dcd-dfabd9138ff2 38 fields · synced Jun 1, 2026