FDA.reportPublic FDA data

Pillow Passive Driver Kit

Primary DI
00850011790229
Brand
Pillow Passive Driver Kit
Company
RESOUNDANT, INC.
Model
REFDAUX
Published
2024-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201389000Resoundant Acoustic Driver SystemResoundant, Inc.2020-07-10LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011790229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011790229008500117902298500117902290850011790229

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic resonance elastography acoustic driverAn assembly of devices, consisting of an electrically-powered pneumatic wave generator and a noninvasive vibration applicator, intended for use with a magnetic resonance imaging (MRI) system to provide a measure of tissue elasticity/stiffness. The generator is used outside the MRI scanner room and is connected by pneumatic tubing to the applicator, which is applied to the site of interest on the patient’s body while within the MRI scanner. The pneumatically-transferred vibrations are applied to the body and MRI images are taken to facilitate evaluation/diagnosis of the condition of tissues (e.g. liver, brain), including damage and tumours.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036969003
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011790168Active DriverRESYS40012022-12-16
00850011790267Active Driver v2RESYS40012025-09-03
00850011790021Resoundant Acoustic Driver SystemRESY3002-RESYSAB2021-05-01
00850011790007MREplusMREplus 3.0.0DKR2021-04-01
00850011790014MREplusMREplus 3.0.0WIN2021-04-01
00850011790045Flex Passive Driver Kit- LargeREFPDL182023-04-01
00850011790052Flex Passive Driver Kit- SmallREFPDS192023-04-01
00850011790106Passive DriverREPD20002023-02-21
00850011790151MR Elastography SystemRESYS4001-RESYSAB2022-12-16
00850011790199Hepatogram Plus 3.0DKRMREPLUSV32022-04-13

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Primary DI, Brand, Company table
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08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
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08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
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