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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 5 of 16

Device	Model / Reference	Registries	Class	Status
Vermed	MQE 9402-034 ARCHIVAL	FDA UDI	Class I	Active
Z-Brand™	Z05MT-50	FDA UDI	Class II	Active
Vermed	SHRPCHEMO 2Q/2L USA YELLOW, ROUND	FDA UDI	Class II	Active
Heartsync by Vermed	T100LOAC-PHYSIO	FDA UDI	Class III	Active
Vermed	IPC71772	FDA UDI	Class II	Active
Vermed	CBG-61596R	FDA UDI	Class II	Active
Vermed	SHRP5.4 QT SHARPS WALL UNIT	FDA UDI	Class II	Active
Z-Brand™	Z05-50 USA	FDA UDI	Class II	Unknown
Vermed	IPC71790	FDA UDI	Class II	Active
Heartsync by Vermed	C100AC-PHYSIO	FDA UDI	Class III	Active
PerformancePlus™	A10005-1-60	FDA UDI	Class II	Unknown
Heartsync by Vermed	T100AC-ZOLL	FDA UDI	Class III	Active
Vermed	SHRPCHEMO 3Q/3L USA YELLOW, SQUARE	FDA UDI	Class II	Active
Vermed	20900-53-GRN	FDA UDI	Class II	Active
VersaTrode™	A10098-30	FDA UDI	Class II	Active
PrImary Care by MDP™	V8930	FDA UDI	Class II	Active
Vermed	CBG-A400-650P	FDA UDI	Class II	Active
Vermed Holter Kit	DAVI01-2	FDA UDI	N/A	Active
Bard	Bard	FDA UDI	Class II	Active
Vermed	MQE 9402-024 GREEN	FDA UDI	Class I	Active
GE Healthcare	2106890-001	FDA UDI	Class II	Unknown
VersaTrode™	A10005SG-5NB	FDA UDI	Class II	Active
NeuroPlus™	A10041-5	FDA UDI	Class II	Active
Vermed	FKD OP-124TE	FDA UDI	Class I	Active
Vermed	NKN PA-7100	FDA UDI	Class I	Active
Vermed	LWG-2300051/5A	FDA UDI	Class II	Active
Guardian™	A10006-60	FDA UDI	Class II	Active
PrImary Care by MDP™	MDP001	FDA UDI	Class II	Unknown
Vermed	LWG-2090S29/5A	FDA UDI	Class II	Active
TenderTrode™	A10057-S	FDA UDI	Class II	Active
GE Healthcare	2106919-001	FDA UDI	Class II	Unknown
GE Healthcare	2106911-001	FDA UDI	Class II	Unknown
GE Healthcare	2104775-001	FDA UDI	Class I	Active
Vermed	Trunk Cable GE MAC PC	FDA UDI	Class II	Active
WestPrime, Beyond Science	L01003	FDA UDI	Class II	Active
VersaTrode™	A10097	FDA UDI	Class II	Unknown
MVAP Medical Supplies	FT006	FDA UDI	Class II	Active
Vermed	CBG-724607R	FDA UDI	Class II	Active
Vermed	IPC71240	FDA UDI	Class II	Active
Vermed	SHRPSHARPS 1Q/0.8L USA RED, ROUND	FDA UDI	Class II	Active
GE Healthcare	2106824-001	FDA UDI	Class I	Active
Vermed	ILS GEM 5508	FDA UDI	Class I	Active
Vermed	CBG-81320R-20	FDA UDI	Class II	Active
Vermed	CBG-721015R/1	FDA UDI	Class II	Active
Vermed	SHRPCHEMO 5Q/5L USA YELLOW, ROUND	FDA UDI	Class II	Active
TenderTrode™	A10001	FDA UDI	Class II	Active
Vermed	IP-Set 12 RT Adult-US	FDA UDI	Class II	Unknown
Vermed	HP 9270-0484	FDA UDI	Class I	Active
Vermed	LWG-3300051/5A	FDA UDI	Class II	Active
Vermed	MQE 9402-020	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.