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
- GAS0047 FDA UDI
- Primary DI / UDI-DI
- 07290110070243 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
- 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
Category: Whole-body plethysmograph
ReDS Pro System by Sensible Medical Innovations Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Whole-body plethysmograph.
- Jaeger — Jaeger Medical GmbH · Class II
- nSpire Health — NSPIRE HEALTH, INC. · Class II
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class II
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class II
- Jaeger — Jaeger Medical GmbH · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- Jaeger — Jaeger Medical GmbH · Class II
Cleared under the same submission
K180479 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sensible Medical Innovations Ltd
Sources (2)
- FDA UDI 80cf39f3-701d-4269-818e-838d3eff3790 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 28, 2026