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Sign in to claim this brandGRAPHIC CONTROLS ACQUISITION CORP
US
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
- —
- —
- [email protected]
- Phone
- 1.800.669.6905
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 002111896
Catalogue (782)
Page 4 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioTens | 700000543 | FDA UDI | Class II | Active |
| PerformancePlus™ | A10005-4NB | FDA UDI | Class II | Active |
| Vermed | IPC71041-8M | FDA UDI | Class II | Active |
| Vermed | SHRP5.4 QT CHEMO WALL UNIT | FDA UDI | Class II | Active |
| Vermed | SIS 43-55-060 | FDA UDI | Class I | Active |
| PerformancePlus™ | A10005NB | FDA UDI | Class II | Active |
| Vermed | PRG-A520-1043N | FDA UDI | Class II | Active |
| Vermed | LWG-3400029RD | FDA UDI | Class II | Active |
| GE Healthcare | 2104770-001 | FDA UDI | Class I | Active |
| TissueLink | 32031774 | FDA UDI | Class II | Unknown |
| Vermed | PHM M3707A | FDA UDI | Class I | Active |
| Z-Brand™ | Z05MC-50 | FDA UDI | Class II | Active |
| Vermed | WA 94016-0000 | FDA UDI | Class I | Active |
| Vermed | A10202 | FDA UDI | Class II | Active |
| Vermed | ELD K140-1010 | FDA UDI | Class I | Active |
| Vermed | 20900-96-RED | FDA UDI | Class II | Active |
| Vermed | NKN FQW110-3-100 | FDA UDI | Class I | Active |
| Vermed | MRN 9100-008 | FDA UDI | Class I | Active |
| Vermed Holter Kit | PMSI01-1 | FDA UDI | N/A | Active |
| Tiny Tab™ | A10027 | FDA UDI | Class II | Active |
| Vermed Holter Kit | KIT-HAN6 | FDA UDI | N/A | Active |
| DEFIB Pads | D326 | FDA UDI | Class III | Unknown |
| Vermed | Trunk Cable GE Case-MAC 5000-CAM14 | FDA UDI | Class II | Active |
| Z-Brand™ | Z05SG-3 | FDA UDI | Class II | Active |
| Vermed | SHRP12 GAL SHARPS W/PORT/DUO LID | FDA UDI | Class II | Active |
| Vermed | Trunk Cable - Physio Control 5 Lead | FDA UDI | Class II | Active |
| Vermed | LWG-40106/I | FDA UDI | Class II | Active |
| Vermed | CBG-721016R/1 | FDA UDI | Class II | Active |
| Guardian™ | A10007-3 | FDA UDI | Class II | Active |
| Vermed | MQE 9402-050 | FDA UDI | Class I | Active |
| Vermed | CBG-A400-900P | FDA UDI | Class II | Active |
| Vermed | CBG-725006/P | FDA UDI | Class II | Active |
| Vermed | Offset Electrode | FDA UDI | Class II | Active |
| TenderTrode Plus™ | A10055-SRT | FDA UDI | Class II | Active |
| Z-Brand™ | Z05MCRT-50 | FDA UDI | Class II | Active |
| Vermed | CBG-72507R | FDA UDI | Class II | Active |
| CarbonClear™ | A10031-60RT | FDA UDI | Class II | Unknown |
| BioZ Advasense by Vermed | BZ-4550-50 | FDA UDI | Class II | Active |
| VersaTrode™ | A10033-5NB | FDA UDI | Class II | Active |
| GE Healthcare | 2106892-001 | FDA UDI | Class II | Unknown |
| GE Healthcare | 2106915-001 | FDA UDI | Class II | Unknown |
| Vermed | IP-Set 5V RT Adult-US | FDA UDI | Class II | Unknown |
| Vermed | IPC71780 | FDA UDI | Class II | Active |
| Vermed Holter Kit | CARD98-3 | FDA UDI | N/A | Active |
| Z-Brand™ | Z05SGRT-30 | FDA UDI | Class II | Active |
| Vermed | SHRP12 GAL CHEMO W/FLAT/MONO LID | FDA UDI | Class II | Active |
| Vermed Holter Kit | GENENJ-7 | FDA UDI | N/A | Active |
| VersaTrode™ | A10007SG-30 | FDA UDI | Class II | Unknown |
| Vermed | A10091-10 | FDA UDI | Class II | Active |
| Vermed | IPC72350 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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. |