FDA.reportPublic FDA data

ReDS Wearabel System

Primary DI
07290110070045
Brand
ReDS Wearabel System
Company
SENSIBLE MEDICAL INNOVATIONS LTD
Model
V2.6
Catalog number
GAS0045
Device description
Fluid status monitorThis 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.
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150095000ReDs Wearable SystemSensible Medical Innovations , Ltd.2015-08-06DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110070045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110070045072901100700457290110070045

GMDN Terms#

Term, Definition table
TermDefinition
Whole-body plethysmographA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855.899.7951customersupport@sensible-medic
855.899.7951customersupport@sensible-medical.com

Regulatory Flags#

DUNS number
532269045
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110070328ReDS Pro SystemV2.76GAS0056-R2021-04-26
07290110070281ReDS SystemV2.6GAS0035-R2020-08-18
07290110070267ReDS Pro SystemV2.7GAS0046-R2020-07-02
07290110070144ReDS Pro SystemV2.7GAS00462019-06-11
07290110070014ReDS Wearable System V2.6GAS00352016-09-01
07290110070021ReDS Wearable SystemV2.6PAK00092016-09-01
07290110070038ReDS Wearable SystemV2.6SAS01202016-09-01
07290110070090ReDS System V2.6GAS00352017-08-22
07290110070106ReDS SystemV2.6PAK00092017-08-22
07290110070113ReDS SystemV2.6SAS01202017-08-22
07290110070120ReDS SystemV2.6GAS00452017-08-22
07290110070205ReDS SystemV2.6GAS00552018-03-05
07290110070212ReDS SystemV2.6GAS00562018-03-05
07290110070540ReDS Pro SystemV2.7GAS0047-R2021-04-12
07290110070243ReDS Pro SystemV2.7GAS00472020-07-02
07290110070151ReDS Pro SystemV2.7PAK00122019-06-11

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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
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