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Paddle

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
Paddle FDA UDI
Generic Name
External defibrillation electrode, paediatric, reusable FDA UDI
Model / Reference
8000-1020 FDA UDI

Identifiers

Primary DI / UDI-DI
00847946023027 FDA UDI
510(k) Number
K062537 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External defibrillation electrode, paediatric, reusable

Paddle by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External defibrillation electrode, paediatric, reusable.

Cleared under the same submission

K062537 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll Medical Corporation

Sources (1)

  • FDA UDI eddb37c5-5c62-47d1-95ca-82b32fd81f2c 34 fields · synced Jun 8, 2026