Defibtech ARM XR Compression Module

FDA UDI

Class II (US FDA UDI)

by Defibtech, L.l.c.

Identity

Trade Name: Defibtech ARM XR Compression Module FDA UDI
Generic Name: Cardiac resuscitator, battery-powered FDA UDI
Model / Reference: RMC-U2000 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815098020812 FDA UDI
510(k) Number: K211289 FDA UDI
FDA Product Code: DRM FDA UDI
GMDN Term: Cardiac resuscitator, battery-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac resuscitator, battery-powered

Defibtech ARM XR Compression Module by Defibtech, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K211289 also covers:

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: Defibtech, L.l.c.

Sources (1)

FDA UDI e3c3e340-3898-421e-959e-fe52422e3dfb 33 fields · synced Jun 6, 2026