FDA.reportPublic FDA data

ReDS System

Primary DI
07290110070106
Brand
ReDS System
Company
SENSIBLE MEDICAL INNOVATIONS LTD
Model
V2.6
Catalog number
PAK0009
Device description
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Wearable System)
Published
2017-08-22
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
07290110070106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110070106072901100701067290110070106

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.

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
Lot or batch
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
07290110070045ReDS Wearabel SystemV2.6GAS00452016-09-01
07290110070090ReDS System V2.6GAS00352017-08-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2026-06-03
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDSB2026-03-16
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCDSB2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCDSB2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDSB2025-09-10
B719G73C0Valhalla Scientific, IncValhalla ScientificDSB2025-07-28
00690103219616ForeSight IQEdwards Lifesciences LLCDSB2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDSB2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDSB2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DSB2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DSB2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DSB2025-03-13
00690103218879HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
B719G62J0Valhalla Scientific, IncValhalla ScientificDSB2024-06-17
B719G63C0Valhalla Scientific, IncValhalla ScientificDSB2024-04-12
B719BE3B0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G61S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15