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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 12 of 16

Device	Model / Reference	Registries	Class	Status
Vermed	MQE 9402-024	FDA UDI	Class I	Active
Z-Brand™	Z05MT-5 USA	FDA UDI	Class II	Unknown
Vermed Holter Kit	KITCOA23	FDA UDI	N/A	Unknown
Vermed	LWG-3400029GR	FDA UDI	Class II	Active
Vermed Holter Kit	KIT-STB100	FDA UDI	N/A	Unknown
Heartsync by Vermed	T100AC-PHYSIO	FDA UDI	Class III	Active
Hillrom	108070	FDA UDI	Class II	Active
NeuroPlus™	A10041-60	FDA UDI	Class II	Active
GE Healthcare	2104778-001	FDA UDI	Class II	Unknown
Vermed	ROH 04352483001	FDA UDI	Class I	Active
Vermed	GE 2030887-001	FDA UDI	Class I	Active
Vermed	A10091-4	FDA UDI	Class II	Active
VersaTrode™	A10005SG-3NB	FDA UDI	Class II	Active
Z-Brand™	Z05MC-3	FDA UDI	Class II	Active
Vermed Holter Kit	CARD98-2	FDA UDI	N/A	Active
VersaTrode™	A10071-5NB	FDA UDI	Class II	Active
Vermed	ECG 100-1012 RED	FDA UDI	Class I	Active
Vermed	V8833	FDA UDI	Class II	Unknown
Vermed	LWG-2300051/3A	FDA UDI	Class II	Active
EMS Electrodes™	A10012-6S	FDA UDI	Class II	Active
Vermed	SHRP12 GAL CHEMO W/PORT/DUO LID	FDA UDI	Class II	Active
Vermed	HP M1707A BLK GRID	FDA UDI	Class I	Active
VersaTrode™	A10098-7NB	FDA UDI	Class II	Active
L.M.C Associates, Inc	LMC 202	FDA UDI	Class II	Active
Vermed	PHM 989803138171	FDA UDI	Class I	Active
Vermed	MQE 9402-020 GREEN	FDA UDI	Class I	Active
Vermed	LWG-3600029/3A	FDA UDI	Class II	Active
Vermed	20100-125-SNAP	FDA UDI	Class II	Active
VersaTrode™	A10033-1-60	FDA UDI	Class II	Active
PerformancePlus™	A10005-10P	FDA UDI	Class II	Active
VersaTrode™	A10032-60	FDA UDI	Class II	Active
ClearScan™	A10006-1-60RT	FDA UDI	Class II	Active
Z-Brand™	Z05MC-5 USA	FDA UDI	Class II	Unknown
Vermed	SHRP18 GAL RCRA W/FLAT/MONO LID	FDA UDI	Class II	Active
Vermed	MQE 9402-037 ARCHIVAL	FDA UDI	Class I	Active
Vermed DEFIB PADS	D319	FDA UDI	Class II	Unknown
Vermed	SIS RXL 63031	FDA UDI	Class I	Active
Vermed	SHRPCHEMO 2Q/2L USA YELLOW, SQUARE	FDA UDI	Class II	Active
Vermed	MQE 9402-021	FDA UDI	Class I	Active
Vermed	MQE 9402-024 3-HOLE	FDA UDI	Class I	Active
P.n.s.™	A10011	FDA UDI	Class II	Active
Vermed Holter Kit	KIT-GOVT089	FDA UDI	N/A	Active
Vermed	V88100	FDA UDI	Class II	Unknown
GE Healthcare	2104772-001	FDA UDI	Class I	Active
Vermed	SCH 2.157 025	FDA UDI	Class I	Active
Vermed	A10091-4	FDA UDI	Class II	Active
Z-Brand™	Z05SGRT-30 USA	FDA UDI	Class II	Unknown
Vermed	SHRP8 GAL RCRA W/FLAT/MONO LID	FDA UDI	Class II	Active
Vermed	SHRPCHEMO 3GAL/12L USA YELLOW, ROUND	FDA UDI	Class II	Active
eNNOVEA Medical, LLC	VQ10031-4	FDA UDI	Class II	Active

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.

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.