Identity
- Trade Name
- Bipolar Cord, Reusable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- MCBICORD1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00699753018969 FDA UDI
- 510(k) Number
- K083194 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrical-only medical device connection cable, reusable
Bipolar Cord, Reusable by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K083194 also covers:
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI a4b97061-f789-4b5e-9aa4-3a48f9d2dfcd 33 fields · synced Jun 9, 2026