FDA.reportPublic FDA data

Vermed

Primary DI
10009336008954
Brand
Vermed
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
Trunk Cable GE MAC PC
Catalog number
32028947
Device description
IP Set Adapter Cable
Published
2018-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101685000IP-SETIntegral Process Sas2010-07-01DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10009336008954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1000933600895410009336008954

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographicA small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.

Contacts#

Phone, Email table
PhoneEmail
800-669-6905info@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00009336008216Vermed20100-125-SNAP20100-125-SNAP2017-02-28
00009336008223Vermed20300-18-RED20300-18-RED2017-02-28
00009336008230Vermed20300-18-WHT20300-18-WHT2017-02-28
00009336008247Vermed20900-18-3A20900-18-3A2017-02-28
00009336008254Vermed20900-24-3A20900-24-3A2018-09-28
00009336008261Vermed20900-53-GRN20900-53-GRN2017-02-28
00009336008278Vermed20900-96-RED20900-96-RED2017-02-28
00009336008315Vermed41656416562017-02-28
00009336008322Vermed20900-18-RED20900-18-RED2017-02-28
00009336008339Vermed20900-48-WHT20900-48-WHT2017-02-28
30009336010630Nissha Medical TechnologiesUltra 210HD Thermal Video Paper320190642026-06-01
10009336010322Zoll PL Defib8900-004041-017000018322023-10-30
10813150020227PerformancePlus™A10005A100052016-09-16
50813150020911NeuroPlus™A10041-5A10041-52017-04-07
00813150020107PerformancePlus™A10005-4NBA10005-4NB2016-09-16
00813150020121PerformancePlus™A10005-60A10005-602016-09-16
00813150020183PerformancePlus™A10005-7NBA10005-7NB2016-09-16
20813150020941NeuroPlus™A10042-10A10042-102017-04-07
20813150020972NeuroPlus™A10043A100432017-04-07
40813150020860NeuroPlus™A10040-5A10041-02017-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09