FDA.reportPublic FDA data

AcQMap

Primary DI
00857042007425
Brand
AcQMap
Company
ACUTUS MEDICAL, INC.
Model
800604
Catalog number
800604
Device description
AcQMap Auxiliary Interface Box, Console 2.0
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
00857042007425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857042007425008570420074258570420074250857042007425

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, interfacingA small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.

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
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
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
00857042007333AcQMap8006018006012022-02-01
00857042007357AcQMap8002558002552022-02-01
00857042007364AcQMap8004058004052022-02-01
00857042007388AcQMap8005318005312022-02-01
00857042007999AcQMap9000009000002022-02-01
00850027837529StabilICE9002189002182021-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10