Identity
- Trade Name
- 3LEAD ECG CABLE DATASCOPE FDA UDI
- Generic Name
- Electrocardiographic electrode connector FDA UDI
- Device Name
- 3LEAD ECG CABLE DATASCOPE FDA UDI
- Model / Reference
- CB-72316 FDA UDI
- Description
- 3LEAD ECG CABLE DATASCOPE FDA UDI
Identifiers
- Catalog Number
- 5506 FDA UDI
- Primary DI / UDI-DI
- 00840828145602 FDA UDI
- 510(k) Number
- K081762 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic electrode connector 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 electrode connector
3lead Ecg Cable Datascope by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8122887c-100a-4b1c-8b01-ff4a53845fc3 36 fields · synced Jun 8, 2026