Identity
- Trade Name
- PK-222-L ECG Cable US FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Model / Reference
- 429748 FDA UDI
Identifiers
- Catalog Number
- 429748 FDA UDI
- Primary DI / UDI-DI
- 04035479157098 FDA UDI
- PMA Number
- P950037 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Electrocardiographic lead set, reusable
PK-222-L ECG Cable US by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — 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
P950037 also covers:
- Amvia Sky HF-T QP — BIOTRONIK SE & Co. KG
- DH — BIOTRONIK SE & Co. KG
- EFH-6F-W — BIOTRONIK SE & Co. KG
- Evity 6 DR-T — BIOTRONIK SE & Co. KG
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG
- M-50 — BIOTRONIK SE & Co. KG
- NEO 2401.U/1 — BIOTRONIK SE & Co. KG
- PK Electrode Clip — BIOTRONIK SE & Co. KG
- PK-222 US/2, 8m — BIOTRONIK SE & Co. KG
- PK-83-B/2, 5m — BIOTRONIK SE & Co. KG
- Renamic — BIOTRONIK SE & Co. KG
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 III | Pending data |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI ccd1da6a-7e03-48d9-b561-ebd6f2c5ab55 36 fields · synced May 30, 2026