Identity
- Trade Name
- Reocor S FDA UDI
- Generic Name
- External pacemaker, transcutaneous pacing FDA UDI
- Model / Reference
- 365528 FDA UDI
Identifiers
- Catalog Number
- 365528 FDA UDI
- Primary DI / UDI-DI
- 04035479110048 FDA UDI
- PMA Number
- P950037 FDA UDI
- FDA Product Code
- OVJ FDA UDI
- GMDN Term
- External pacemaker, transcutaneous pacing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3600 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External pacemaker, transcutaneous pacing
Reocor S by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External pacemaker, transcutaneous pacing.
- Reocor S Redeladapter — BIOTRONIK SE & Co. KG · Class II
- Reocor D — BIOTRONIK SE & Co. KG · Class II
- Reocor D Redeladapter — BIOTRONIK SE & Co. KG · 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 II | Pending data |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
Sources (1)
- FDA UDI 3568585a-14cf-4642-a031-4d6e948f7338 35 fields · synced May 30, 2026