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Agile TEst

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
Agile TEst FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
TEST FDA UDI
Model / Reference
test FDA UDI
Description
TEST FDA UDI

Identifiers

Primary DI / UDI-DI
00847946020613 FDA UDI
510(k) Number
K120907 FDA UDI
FDA Product Code
DQA FDA UDI
DRO FDA UDI
CCK FDA UDI
LDD FDA UDI
DXN FDA UDI
DRT FDA UDI
MKJ FDA UDI
LIX FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
870.5550 FDA UDI
868.1400 FDA UDI
870.5300 FDA UDI
870.1130 FDA UDI
870.2300 FDA UDI
870.5310 FDA UDI
870.5210 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

Agile TEst 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

K120907 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 148503b4-cc59-4f9c-8514-0eec266283b5 36 fields · synced Jun 8, 2026