Identity
- Trade Name
- Vermed FDA UDI
- Generic Name
- Patient monitoring system module, electrocardiographic FDA UDI
- Device Name
- IP Set ECG Adapter Cable FDA UDI
- Model / Reference
- IPC72477 FDA UDI
- Description
- IP Set ECG Adapter Cable FDA UDI
Identifiers
- Catalog Number
- 4009872C FDA UDI
- Primary DI / UDI-DI
- 15060441914771 FDA UDI
- 510(k) Number
- K101685 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Patient monitoring system module, electrocardiographic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Patient monitoring system module, electrocardiographic
Vermed by Graphic Controls Acquisition Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, electrocardiographic.
- AMC — Advantage Medical Electronics, LLC · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
- BNC head ECG Lead(FDA ) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Iradimed — Iradimed Corporation · Class II
- ECG Module Kit(AHA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- ECG module — Shenzhen Wisonic Medical Technology Co., Ltd. · Class II
- ECG Module Kit(2143/AHA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- ECG Module Kit(AHA/RE6) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K101685 also covers:
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
- Vermed — GRAPHIC CONTROLS ACQUISITION CORP
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Graphic Controls Acquisition Corp
Sources (1)
- FDA UDI a5a379d0-9a77-43b2-a5e4-cb79c5d50742 36 fields · synced May 30, 2026