Identity
- Trade Name
- Model 6653 FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 405231 FDA UDI
Identifiers
- Catalog Number
- 405231 FDA UDI
- Primary DI / UDI-DI
- 04035479143541 FDA UDI
- PMA Number
- P950037 FDA UDI
- FDA Product Code
- OVJ FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3600 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Model 6653 by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI ee8ed5b2-db15-417b-9974-bb9bcfe92788 37 fields · synced Jun 6, 2026