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GRAPHIC CONTROLS ACQUISITION CORP

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: —
Email: [email protected]
Phone: 1.800.669.6905
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 002111896

Catalogue (782)

Page 8 of 16

Device	Model / Reference	Registries	Class	Status
ClearScan™	A10004-60	FDA UDI	Class II	Active
Vermed	SHRPSHARPS 4Q/4L USA RED, SQUARE	FDA UDI	Class II	Active
Z-Brand™	Z05MTRT-5 USA	FDA UDI	Class II	Unknown
Vermed	PR-A520-1013P	FDA UDI	Class II	Active
Vermed	MQE 9402-018	FDA UDI	Class I	Active
Vermed	ZL 8000-000901	FDA UDI	Class I	Active
Vermed	LWG-2500024RD	FDA UDI	Class II	Active
Vermed	IPC71774	FDA UDI	Class II	Active
Vermed DEFIB PADS	D317	FDA UDI	Class II	Unknown
Vermed	ECG 100-1022 GREEN	FDA UDI	Class I	Active
Vermed	IPC71792	FDA UDI	Class II	Active
NeuroPlus™	A10050-60	FDA UDI	Class II	Active
Vermed	BDK 007868	FDA UDI	Class I	Active
Vermed	BDK 007966	FDA UDI	Class I	Active
ACS Diagnostics	4105DEL7	FDA UDI	Class II	Active
Vermed	IPC71818	FDA UDI	Class II	Active
Vermed DEFIB PADS	D310	FDA UDI	Class III	Unknown
Vermed	MRN 9100-028-50	FDA UDI	Class I	Active
EMS Electrodes™	A10084-4	FDA UDI	Class II	Active
Vermed	QUT 18416-001	FDA UDI	Class I	Active
Vermed	SIS 101404	FDA UDI	Class I	Active
Vermed	IPC72711	FDA UDI	Class II	Active
Vermed	IP-Set M3 RT Adult-US	FDA UDI	Class II	Unknown
NeuroPlus™	A10042-60	FDA UDI	Class II	Active
SofTouch™	A10070-1-60	FDA UDI	Class II	Active
Vermed	FKD OP-219TE	FDA UDI	Class I	Active
TissueLink	32031771	FDA UDI	Class II	Unknown
Vermed	SHRP8 GAL PHARMA W/PORT/DUO LID	FDA UDI	Class II	Active
Vermed DEFIB PADS	D313	FDA UDI	Class III	Unknown
Vermed Holter Kit	KIT-VAN	FDA UDI	N/A	Active
Vermed	QUT 16211-002	FDA UDI	Class I	Active
Vermed	BDK 007868-0002	FDA UDI	Class I	Active
TenderTrode Plus™	A10058-SRT	FDA UDI	Class II	Active
GE Healthcare	2104777-001	FDA UDI	Class II	Unknown
Vermed Holter Kit	KIT-SIE1	FDA UDI	N/A	Unknown
Vermed	IPC72835	FDA UDI	Class II	Active
Latitude™	32031693	FDA UDI	Class I	Active
Vermed	20900-18-3A	FDA UDI	Class II	Active
Vermed	NKN FQW50-3-100	FDA UDI	Class I	Active
Vermed	LWG-2090S29/6A	FDA UDI	Class II	Active
Vermed Holter Kit	CARE01-01	FDA UDI	N/A	Active
Z-Brand™	Z05MCRT-50 USA	FDA UDI	Class II	Unknown
Embla	1410500	FDA UDI	Class II	Active
PerformancePlus™	A10005-7NB	FDA UDI	Class II	Active
Vermed	LWG-2090029GR	FDA UDI	Class II	Active
Vermed	LWG-2090029WH	FDA UDI	Class II	Active
Vermed	ZL 8000-0300	FDA UDI	Class I	Active
Vermed	LWG-2500024WH	FDA UDI	Class II	Active
Vermed	CBG-71316R-DS	FDA UDI	Class II	Active
Vermed	HP 40477A	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.

Date	Recall No.	Class	Status	Reason
Mar 15, 2022	Z-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, 2022	Z-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, 2022	Z-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, 2022	Z-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, 2022	Z-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, 2022	Z-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.