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Sensor

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
Sensor FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
SENSOR, CAPNOSTAT 5, E SERIES FDA UDI
Model / Reference
9355-0307 FDA UDI
Description
SENSOR, CAPNOSTAT 5, E SERIES FDA UDI

Identifiers

Primary DI / UDI-DI
00847946021672 FDA UDI
00847946024215 FDA UDI
510(k) Number
K090989 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 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: Rechargeable professional automated external defibrillator

Sensor 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.

Cleared under the same submission

K090989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll Medical Corporation

Sources (2)

  • FDA UDI f341145f-5e76-43d0-8b5a-15d0c4270d71 35 fields · synced Jun 8, 2026
  • FDA UDI f8630bfa-8500-44bd-8c86-ff1c27f596fe 35 fields · synced May 27, 2026