Identity
- Trade Name
- INTEGRAL PROCESS Cables & Leadwires FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- SET OF 10 BANANA LEADWIRES - AAMI FOR INTEGRAL PROCESS TRUNK CABLE FDA UDI
- Model / Reference
- ECG Cable FDA UDI
- Description
- SET OF 10 BANANA LEADWIRES - AAMI FOR INTEGRAL PROCESS TRUNK CABLE FDA UDI
Identifiers
- Catalog Number
- 70644NGJ10-US FDA UDI
- Primary DI / UDI-DI
- 03700506319411 FDA UDI
- 510(k) Number
- K162768 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
Category: Electrocardiographic lead set, reusable
INTEGRAL PROCESS Cables & Leadwires by Nissha Medical Technologies Sas — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- 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
K162768 also covers:
- Bard — GRAPHIC CONTROLS ACQUISITION CORP
- Biosense — GRAPHIC CONTROLS ACQUISITION CORP
- Physio Control — GRAPHIC CONTROLS ACQUISITION CORP
- St Jude Medical — GRAPHIC CONTROLS ACQUISITION CORP
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
- INTEGRAL PROCESS Cables & Leadwires — NISSHA MEDICAL TECHNOLOGIES SAS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Sas
Sources (2)
- FDA UDI ddf61ac0-b43d-4fde-95ca-bcf496da8908 37 fields · synced Oct 8, 2026
- EUDAMED 1 fields · synced Jun 2, 2026