FDA.reportPublic FDA data

Maguire

Primary DI
G662ME3641
Brand
Maguire
Company
Maguire Enterprises, Inc.
Model
ME364
Catalog number
ME364
Device description
Interconnect Hyperbaric
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G662ME3641PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Regulatory Flags#

DUNS number
151769494
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G662ME5900951MaguireME590095ME5900952026-07-29
G662ME590333B1MaguireME590333BME590333B2026-07-29
G662ME590280L1MaguireME590280LME590280L2026-07-28
G662ME590280M1MaguireME590280MME590280M2026-07-28
G662ME590280T11MaguireME590280T1ME590280T12026-07-28
G662ME590280Y1MaguireME590280YME590280Y2026-07-28
G662ME5900321MaguireME590032ME5900322026-07-23
G662ME590030R1MaguireME590030RME590030R2026-07-14
G662ME590030M31MaguireME590030M3ME590030M32026-06-24
G662ME5921011MaguireME592101ME5921012026-06-10
G662ME550LP121MaguireME550LP12ME550LP122026-05-06
G662ME584J1MaguireME584JME584J2026-04-30
G662ME5900941MaguireME590094ME5900942026-04-27
G662ME3681MaguireME368ME3682026-04-20
G662ME5903011MaguireME590301ME5903012026-04-15
G662ME590301F1MaguireME590301FME590301F2026-04-15
G662ME550CS1F1MaguireME550CS1FME550CS1F2026-04-07
G662ME5901751MaguireME590175ME5901752026-03-27
G662ME590032P1MaguireME590032PME590032P2026-03-26
G662ME550MDR1MaguireME550MDRME550MDR2026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
04048675379300IBP Cable UtahDrägerwerk AG & Co. KGaADSA2026-01-07
04048675557722IBP Adapter Cable Dräger 7pinDrägerwerk AG & Co. KGaADSA2026-01-07
04048675379072IBP cable Becton DickinsonDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379089IBP Cable Abbott, MedexDrägerwerk AG & Co. KGaADSA2026-01-06
04048675379096IBP cable EdwardsDrägerwerk AG & Co. KGaADSA2026-01-06
04048675557739IBP Adapter Cable Drager 10pinDrägerwerk AG & Co. KGaADSA2026-01-06
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08