Identity
- Trade Name
- R SERIES FDA UDI
- Generic Name
- Rechargeable professional automated external defibrillator FDA UDI
- Device Name
- MULTIFUNCTION THERAPY CABLE WITH CPR-D CONNECTOR, R SERIES, MULTI-LANG FDA UDI
- Model / Reference
- 1009-000208-40 FDA UDI
- Description
- MULTIFUNCTION THERAPY CABLE WITH CPR-D CONNECTOR, R SERIES, MULTI-LANG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946023379 FDA UDI
- 510(k) Number
- K102174 FDA UDI
- FDA Product Code
- CCK FDA UDIDXN FDA UDIDSK FDA UDIDRT FDA UDIDQA FDA UDI
- GMDN Term
- Rechargeable professional automated external defibrillator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI870.1130 FDA UDI870.1110 FDA UDI870.2300 FDA UDI870.2700 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
No
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: Rechargeable professional automated external defibrillator
R Series by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rechargeable professional automated external defibrillator.
- HeartStart — PHILIPS ELECTRONICS NORTH AMERICA CORPORATION · Class III
- M SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class III
- E SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class II
- X SERIES — Zoll Medical Corporation · Class III
- X SERIES — Zoll Medical Corporation · Class II
Cleared under the same submission
K102174 also covers:
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
- PROPAQ M — Zoll Medical Corporation
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
- Zoll Medical Corporation
Sources (1)
- FDA UDI f35a252d-9085-40c3-a66a-a01e88acfc53 35 fields · synced Jun 8, 2026