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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 1 of 16

Device	Model / Reference	Registries	Class	Status
MVAP Medical Supplies	FT002	FDA UDI	Class II	Active
Vermed	ELD K140-1020	FDA UDI	Class I	Active
PerformancePlus™	A10072-1-7P	FDA UDI	Class II	Active
VersaTrode™	A10032-5	FDA UDI	Class II	Active
TenderTrode Plus™	A10008	FDA UDI	Class II	Active
Vermed	HP 40457A	FDA UDI	Class I	Active
Vermed	SHRP8 GAL RCRA W/PORT/DUO LID	FDA UDI	Class II	Active
NeuroPlus™	A10040-60	FDA UDI	Class II	Active
Vermed	GE 74205-HEL	FDA UDI	Class I	Active
Vermed	SHRPCHEMO 2GAL/7L USA YELLOW, ROUND	FDA UDI	Class II	Active
Vermed DEFIB PADS	D315	FDA UDI	Class III	Unknown
Vermed	SIS 45-26-208	FDA UDI	Class I	Active
Vermed	LWG-2090029RD	FDA UDI	Class II	Active
Vermed	SCH 2.157.007A	FDA UDI	Class I	Active
Vermed	IPC71788	FDA UDI	Class II	Active
Vermed	FKD OP-69TE	FDA UDI	Class I	Active
VersaTrode™	A10005-7%-7P	FDA UDI	Class II	Active
Vermed	Offset Electrode	FDA UDI	Class II	Active
Heartsync by Vermed	C100AC	FDA UDI	Class II	Active
PerformancePlus™	A10005	FDA UDI	Class II	Active
VersaTrode™	A10097-3	FDA UDI	Class II	Active
Vermed Holter Kit	LAKE10-1	FDA UDI	N/A	Active
Vermed Holter Kit	SEID01-3	FDA UDI	N/A	Active
Vermed	IPC72477-4M	FDA UDI	Class II	Active
Vermed	CBG-72307R	FDA UDI	Class II	Active
Vermed	Trunk Cable Philips TC30-TC50-TC70	FDA UDI	Class II	Active
Vermed	LTN 781-080-12	FDA UDI	Class I	Active
Vermed	SOM EP4	FDA UDI	Class I	Active
Vermed	CMS 4525AAO	FDA UDI	Class I	Active
Z-Brand™	Z05SGRT-5NB USA	FDA UDI	Class II	Unknown
Guardian™	A10006-3-30	FDA UDI	Class II	Active
ClearScan™	A10004-5	FDA UDI	Class II	Active
Vermed	V8930	FDA UDI	Class II	Unknown
Vermed	LWG-440002910/90	FDA UDI	Class II	Active
Vermed	GE 008156	FDA UDI	Class I	Active
EMS Electrodes™	A10052-10S	FDA UDI	Class II	Active
eNNOVEA Medical, LLC	VQ10031	FDA UDI	Class II	Active
Vermed	CMS 4305 (40/CA)	FDA UDI	Class I	Active
Vermed	SHRPSHARPS BIO 5Q/5L YELLOW, SQUARE	FDA UDI	Class II	Active
Vermed	IPC71940	FDA UDI	Class II	Active
Vermed	IP-Set 6V RT ADULT-US	FDA UDI	Class II	Unknown
Vermed	ECG 110-1020 GREEN	FDA UDI	Class I	Active
VersaTrode™	A10098-3NB	FDA UDI	Class II	Unknown
Vermed	20900-24-3A	FDA UDI	Class II	Active
L.M.C Associates, Inc.	LMC 303	FDA UDI	Class II	Active
Vermed Holter Kit	ERES01-1	FDA UDI	N/A	Active
Vermed Holter Kit	000-400-0060	FDA UDI	N/A	Unknown
PrImary Care by MDP™	V88100	FDA UDI	Class II	Active
Vermed	LWG-3400029/5A	FDA UDI	Class II	Active
Vermed	MQE 9402-046	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.