Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

GRAPHIC CONTROLS ACQUISITION CORP

US

Last updated May 24, 2026

What GRAPHIC CONTROLS ACQUISITION CORP makes

Graphic Controls Acquisition Corp manufactures electrocardiographic electrodes, recording paper, lead sets, and monitoring system modules for cardiac monitoring. They also produce cytotoxic waste containers, sharps containers, and analytical non-scalp cutaneous electrodes for clinical and laboratory use.

The company's devices span Class I, II, and III classifications and are listed in the FDA's Unique Device Identification (fda_udi) system. Graphic Controls Acquisition Corp is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Graphic Controls Acquisition Corp manufacture?

Graphic Controls Acquisition Corp produces a range of cardiac monitoring products, including single-use electrocardiographic electrodes, recording paper, reusable lead sets, long‑term ambulatory recording kits, and modules for patient monitoring systems. In addition, they make cytotoxic waste containers, sharps containers, and analytical non‑scalp cutaneous electrodes for clinical and laboratory environments. This answer reflects the device categories listed in the provided data.

Where is Graphic Controls Acquisition Corp based and which regulatory listing includes its devices?

The company is based in the United States, as indicated by the COUNTRY field. All of its devices are listed in the FDA’s Unique Device Identification (UDI) system, which is the registry mentioned under LISTED IN. This information comes directly from the supplied data.

How are the devices from Graphic Controls Acquisition Corp classified under FDA regulations?

The devices span all three FDA risk classes: Class I, Class II, and Class III. This classification range is explicitly stated in the DEVICE CLASSES section, indicating that some of their products are low risk (Class I), others moderate risk (Class II), and some high risk (Class III).

Which specific product names are associated with Graphic Controls Acquisition Corp’s electrocardiographic offerings?

Examples of product names linked to their electrocardiographic line include PerformancePlus™, VersaTrode™, TenderTrode Plus™, and NeuroPlus™. These names appear in the EXAMPLE DEVICES list and correspond to the electrocardiographic electrode and monitoring categories described in the summary.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
vermed.com
LinkedIn
—
Facebook
—
Phone
1.800.669.6905
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
002111896

Catalogue (782)

Page 14 of 16
DeviceModel / ReferenceRegistriesClassStatus
VersaTrode™ A10005SG-30
FDA UDI
Class IIUnknown
Vermed SHRP8 GAL CHEMO W/FLAT/MONO LID
FDA UDI
Class IIActive
L.M.C Associates, Inc. LMC 404
FDA UDI
Class IIActive
Z-Brand™ Z05SG-30
FDA UDI
Class IIActive
Vermed DEFIB PADS D303
FDA UDI
Class IIIUnknown
Z-Brand™ Z05MT-3 USA
FDA UDI
Class IIUnknown
Vermed P10097-5NB
FDA UDI
Class IIActive
Vermed SHRPCHEMO 1.5Q/1.5L USA YELLOW ROUND
FDA UDI
Class IIActive
Z-Brand™ Z05SG-5
FDA UDI
Class IIActive
Vermed V8955
FDA UDI
Class IIActive
Vermed LWG-3400V29/5A
FDA UDI
Class IIActive
Z-Brand™ Z35RT-3
FDA UDI
Class IIActive
Vermed Holter Kit ALBU17-1
FDA UDI
N/AUnknown
Vermed LWG-2090029BK
FDA UDI
Class IIActive
SilveRest™ A10009-100F
FDA UDI
Class IIActive
Vermed SHRP12 GAL RCRA W/PORT/DUO LID
FDA UDI
Class IIActive
Vermed CBG-721038R/1
FDA UDI
Class IIActive
Vermed RMR 984-070
FDA UDI
Class IActive
Biosense CARTO3
FDA UDI
Class IIActive
Heartsync by Vermed PEDIATRIC-ZOLL
FDA UDI
Class IIActive
Z-Brand™ Z35-50 USA
FDA UDI
Class IIUnknown
Z-Brand™ Z05MTRT-5
FDA UDI
Class IIActive
Vermed LWG-3300051BR
FDA UDI
Class IIActive
Vermed DEFIB PADS D316
FDA UDI
Class IIIActive
PerformancePlus™ A10072-1-60
FDA UDI
Class IIUnknown
PerformancePlus™ A10072-5
FDA UDI
Class IIActive
Vermed Holter Kit KIT-MED37A
FDA UDI
N/AActive
Vermed HP M1910A
FDA UDI
Class IActive
Z-Brand™ Z05MC-3 USA
FDA UDI
Class IIUnknown
Z-Brand™ Z05SG-50
FDA UDI
Class IIActive
Guardian™ A10006-60T
FDA UDI
Class IIActive
ClearScan™ A10006-5RT
FDA UDI
Class IIActive
MVAP Medical Supplies FT005-REF
FDA UDI
Class IIActive
BioZ Advasense by Vermed BZ-1550-50
FDA UDI
Class IIActive
Vermed MRN 9100-026-50
FDA UDI
Class IActive
PerformancePlus™ A10076
FDA UDI
Class IIActive
Vermed SPA 307568
FDA UDI
Class IActive
Vermed LWG-2500024BR
FDA UDI
Class IIActive
Vermed IPC72732
FDA UDI
Class IIActive
Vermed IPC71771
FDA UDI
Class IIActive
Vermed SHRPSHARPS 5Q/5L USA RED, SQUARE
FDA UDI
Class IIActive
Z-Brand™ Z05MT-50 USA
FDA UDI
Class IIUnknown
Vermed IP-Set N3-Pediatric-US
FDA UDI
Class IIUnknown
Vermed SIS 5773
FDA UDI
Class IActive
VersaTrode™ A10098-5NB
FDA UDI
Class IIActive
NeuroPlus™ A10041-6
FDA UDI
Class IIActive
Vermed VLG 20200
FDA UDI
Class IActive
PerformancePlus™ A10072-1-60
FDA UDI
Class IIActive
Vermed Offset Electrode
FDA UDI
Class IIActive
Vermed PRG-A520-1011
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Graphic Controls Acquisition Corp. has six recall records, all initiated on 2022-03-15, with each listed as terminated. The recalls pertain to ECG trunk cables and patient leadwires, where the Instructions for Use (IFU) referenced compliance with ANSI/AAMI EC53:2013/(R)2020, specifically noting a requirement for the device to withstand 5,000 V DC when used with a defibrillator, as outlined in Section 5.3.9 of the standard.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Mar 15, 2022Z-0938-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

Mar 15, 2022Z-0937-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

Mar 15, 2022Z-0940-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

Mar 15, 2022Z-0939-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

Mar 15, 2022Z-0935-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

Mar 15, 2022Z-0936-2022—terminated

Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.