FDA.reportPublic FDA data

AcQMap

Primary DI
00857042007357
Brand
AcQMap
Company
ACUTUS MEDICAL, INC.
Model
800255
Catalog number
800255
Device description
Workstation Cable
Published
2022-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857042007357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857042007357008570420073578570420073570857042007357

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(442)232-6100product.complaints@acutus.com

Regulatory Flags#

DUNS number
844418199
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857042007142AcQRef9000059000052021-10-15
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
00857042007906AcQGuide VUE9002019002012022-05-13
00850027837017AcQGuide MAX9002009002002021-10-08
00857042007432AcQGuide1128522019-07-24
00857042007456AcQGuide1228521228522019-07-24
00857042007012AcQGuide9000029000022018-02-15
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837635DiamondTemp Generator Adapter8008188008182022-10-24
00850027837642StabilICE9002219002212022-04-01
00850027837659StabilICE9002189002182022-04-01
00850027837192AcQMap8006988006982022-02-01
00850027837222AcQMap8006958006952022-02-01
00850027837239AcQMap8006968006962022-02-01
00850027837246AcQMap8006978006972022-02-01
00850027837444AcQMap8007108007102022-02-01
00850027837451AcQMap8007398007392022-02-01
00850027837468AcQMap8007428007422022-02-01
00850027837475AcQMap8007458007452022-02-01
00850027837482AcQMap8007488007482022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
00850050934288EndoSound® EVS™ SideKick 5107Endosound, Inc.IYO2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-10-28
08683255231881GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIITX2026-10-27
08800159500060S-Patch CardioAIWellysis Corp.DQK2026-10-27
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
00860009793538STAR ArtemisRhythm AI Inc.DQK2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
03770033463055FETOLYDIAGNOLYIYO2026-10-22
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09