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Pads, DDU-2XXX series, Adult Rescue 1 pair

FDA UDI

Class III (US FDA UDI)

by Defibtech, L.l.c.

Identity

Trade Name: Pads, DDU-2XXX series, Adult Rescue 1 pair FDA UDI
Generic Name: External defibrillation electrode, adult, single-use FDA UDI
Model / Reference: DDP-2001 FDA UDI

Identifiers

Primary DI / UDI-DI: 10815098020444 FDA UDI
PMA Number: P160032 FDA UDI
FDA Product Code: MKJ FDA UDI
GMDN Term: External defibrillation electrode, adult, single-use FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 870.5310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External defibrillation electrode, adult, single-use

Pads, DDU-2XXX series, Adult Rescue 1 pair by Defibtech, L.l.c. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as External defibrillation electrode, adult, single-use.

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Cleared under the same submission

P160032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer: Defibtech, L.l.c.

Sources (1)

FDA UDI fa48556d-2abe-4719-b037-fc9740d11e95 33 fields · synced May 30, 2026