Identity
- Trade Name
- ECG Cable for CM 3000-12 BT / SEER 12 FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). FDA UDI
- Model / Reference
- 10 Leads, 105 cm, IEC Color Code, Flat FDA UDI
- Description
- The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). FDA UDI
Identifiers
- Catalog Number
- 2104809-001 FDA UDI
- Primary DI / UDI-DI
- 04250903201714 FDA UDI
- 510(k) Number
- K063042 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
ECG Cable for CM 3000-12 BT / SEER 12 by getemed Medizin- und Informationstechnik AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K063042 also covers:
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 — getemed Medizin- und Informationstechnik AG
- ECG Cable for CM 3000-12 BT / SEER 12 10 Leads — getemed Medizin- und Informationstechnik AG
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
- getemed Medizin- und Informationstechnik AG
Sources (1)
- FDA UDI 2e808543-17ea-4248-be22-77dc26b5698a 37 fields · synced May 30, 2026