Identity
- Trade Name
- PEDIATRIC PADDLE ADAPTER FDA UDI
- Generic Name
- External defibrillation electrode, paediatric, reusable FDA UDI
- Device Name
- ASSY PEDIATRIC PADDLE,ENG, 3RD EDITION FDA UDI
- Model / Reference
- 11133 FDA UDI
- Description
- ASSY PEDIATRIC PADDLE,ENG, 3RD EDITION FDA UDI
Identifiers
- Catalog Number
- 11133-000001 FDA UDI
- Primary DI / UDI-DI
- 00883873796146 FDA UDI
- 510(k) Number
- K142430 FDA UDI
- FDA Product Code
- LDD FDA UDI
- GMDN Term
- External defibrillation electrode, paediatric, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5300 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: External defibrillation electrode, paediatric, reusable
Pediatric Paddle Adapter by PHYSIO-CONTROL, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, paediatric, reusable.
- X SERIES MONITOR/DEFIBRILLATOR — Zoll Medical Corporation · Class III
- Paddle — Zoll Medical Corporation · Class II
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
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA UDI f9d39868-8bba-4311-8279-e5a14f8b8aad 36 fields · synced Jun 9, 2026