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ReDS Pro System

FDA UDI

Class II (US FDA UDI)

by Sensible Medical Innovations Ltd

Identity

Trade Name
ReDS Pro System FDA UDI
Generic Name
Whole-body plethysmograph FDA UDI
Device Name
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Pro System) FDA UDI
Model / Reference
V2.7 FDA UDI
Description
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Pro System) FDA UDI

Identifiers

Catalog Number
PAK0012 FDA UDI
Primary DI / UDI-DI
07290110070151 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Whole-body plethysmograph

ReDS Pro System by Sensible Medical Innovations Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Whole-body plethysmograph.

Cleared under the same submission

K180479 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sensible Medical Innovations Ltd

Sources (1)

  • FDA UDI 4b511ad8-76d1-4ad1-be01-3d26fb067ad1 37 fields · synced May 30, 2026