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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 10 of 16

Device	Model / Reference	Registries	Class	Status
GE Healthcare	2106921-001	FDA UDI	Class II	Unknown
Vermed	IP-Set M3 RT Adult-US	FDA UDI	Class II	Unknown
Vermed	IPC72262	FDA UDI	Class II	Active
DuraTENS	700000548	FDA UDI	Class II	Active
TenderTrode™	A10000-60	FDA UDI	Class II	Unknown
Vermed Holter Kit	KIT-DAV2	FDA UDI	N/A	Unknown
Vermed	QUT 16631-002	FDA UDI	Class I	Active
Vermed	IPC72520	FDA UDI	Class II	Active
TenderTrode™	A10060-SRT	FDA UDI	Class II	Active
ClearScan™	A10031-50RT	FDA UDI	Class II	Active
GE Healthcare	2106924-001	FDA UDI	Class II	Unknown
Vermed	IP-Set M5 RT Adult-US	FDA UDI	Class II	Unknown
Vermed	LWG-6090029/3A	FDA UDI	Class II	Active
Vermed	LWG-3300029/3A	FDA UDI	Class II	Active
Vermed	AMS 129356-116	FDA UDI	Class I	Active
Vermed	NKN PA-8300	FDA UDI	Class I	Active
ClearScan™	A10025T-60	FDA UDI	Class II	Active
Vermed	SCH 2.157 026	FDA UDI	Class I	Active
Vermed	CBG-A400-1011D4	FDA UDI	Class II	Active
Vermed	CBG-721015R/1I	FDA UDI	Class II	Active
Vermed	HP M1707A-0001	FDA UDI	Class I	Active
Vermed	GPS FTP-040P001	FDA UDI	Class I	Active
ClearScan™	A10004-60T	FDA UDI	Class II	Active
Vermed	EDN CADENCE	FDA UDI	Class I	Active
Vermed	EDN SE-12P	FDA UDI	Class I	Active
Vermed	V8950	FDA UDI	Class II	Active
Heartsync by Vermed	T100LOAC	FDA UDI	Class II	Active
Vermed	IPC72360	FDA UDI	Class II	Active
Vermed	IPC72466	FDA UDI	Class II	Active
Vermed	PHY 804700	FDA UDI	Class I	Active
MVAP Medical Supplies	FT005	FDA UDI	Class II	Active
Vermed	IPC71043	FDA UDI	Class II	Active
Vermed	PRG-A900-1006V	FDA UDI	Class II	Active
Vermed	LWG-3400029/5I	FDA UDI	Class II	Active
Vermed	PPR MEC PPR7830B	FDA UDI	Class I	Active
HeartSync by Vermed	C100LOAC-PHYSIO	FDA UDI	Class III	Active
GE Healthcare	2104908-001	FDA UDI	Class I	Active
EMS Electrodes™	A10003-4-60	FDA UDI	Class II	Active
Vermed	HP M1709A	FDA UDI	Class I	Active
St Jude Medical	St Jude Medical	FDA UDI	Class II	Active
Heartsync by Vermed	PED-100	FDA UDI	Class II	Active
PerformancePlus™	A10012-5S	FDA UDI	Class II	Active
GE Healthcare	2106823-001	FDA UDI	Class I	Active
Vermed	MQE 9402-060	FDA UDI	Class I	Active
VersaTrode™	A10005-7%-5P	FDA UDI	Class II	Active
Vermed	MRY PM-9000	FDA UDI	Class I	Active
SilveRest™	A10013-100S	FDA UDI	Class II	Active
Z-Brand™	Z35-3 USA	FDA UDI	Class II	Unknown
Vermed	GTG 61301600005	FDA UDI	Class I	Active
DuraTENS	700000547	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.