Identity
- Trade Name
- 1PC TRK CBL,3LD,NIHON KOHDEN,SNAP,10',45 FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- 1PC TRK CBL,3LD,NIHON KOHDEN,SNAP,10',45 FDA UDI
- Model / Reference
- MCB-03VA-10AS-0100 FDA UDI
- Description
- 1PC TRK CBL,3LD,NIHON KOHDEN,SNAP,10',45 FDA UDI
Identifiers
- Catalog Number
- 25747 FDA UDI
- Primary DI / UDI-DI
- 00840828177221 FDA UDI
- 510(k) Number
- K081762 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic lead set, reusable
1pc Trk Cbl, 3ld, Nihon Kohden, Snap, 10', 45 by Curbell Medical Products, Inc. — 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
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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
K081762 also covers:
- 3-LD DIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD ECG CABLE, MOLDED, SNAP, A, RISISTO — CURBELL MEDICAL PRODUCTS, INC.
- 3-LD TWIN ECG CABLE, ACUSON SEQUOIA /90 — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD DIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD ECG CABLE DATEX TO GE LEADS — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD ECG CABLE, MOLDED, SNAP, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD TWIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- 5-LD TWIN ECG CABLE, A — CURBELL MEDICAL PRODUCTS, INC.
- CBL 024, PLP, MLD, 3LEAD, SNAP, 10FT, AHA — CURBELL MEDICAL PRODUCTS, INC.
- CBL 024, PLP, TWINPIN, 5LEAD, YOKE10FT, AHA — CURBELL MEDICAL PRODUCTS, INC.
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
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 07321e07-fadc-41cc-a97b-fa304ea8912a 36 fields · synced May 31, 2026