Identity
- Trade Name
- SCHILLER FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Sensor for MAGLIFE Serenity. FDA UDI
- Model / Reference
- ECG sensor type IV FDA UDI
- Description
- ECG Sensor for MAGLIFE Serenity. FDA UDI
Identifiers
- Catalog Number
- 0-13-0015 FDA UDI
- Primary DI / UDI-DI
- 07613365900026 FDA UDI
- 510(k) Number
- K023195 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
Schiller by Schiller Medical — Class II — 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
K023195 also covers:
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
- SCHILLER — SCHILLER MEDICAL
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
- Schiller Medical
Sources (1)
- FDA UDI 819c9f6a-cfce-4a80-abad-08c6555d65e6 36 fields · synced Jun 6, 2026