ROSC-U, Battery Control Unit

FDA UDI

Class II (US FDA UDI)

by Resuscitation International

Identity

Trade Name: ROSC-U, Battery Control Unit FDA UDI
Generic Name: Cardiac resuscitator, battery-powered FDA UDI
Device Name: Battery Control Unit FDA UDI
Model / Reference: A03-1B-000 FDA UDI
Description: Battery Control Unit FDA UDI

Identifiers

Catalog Number: A03-1B-000 FDA UDI
Primary DI / UDI-DI: 00860000876216 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

Yes

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

FDA UDI

Category: Cardiac resuscitator, battery-powered

ROSC-U, Battery Control Unit by Resuscitation International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac resuscitator, battery-powered.

Defibtech ARM XR Compression Module Configuration — DEFIBTECH, L.L.C. · Class II
Defibtech ARM XR Compression Module — DEFIBTECH, L.L.C. · Class II
AutoPulse®Resuscitation System — ZOLL Circulation, Inc. · Class II
Defibtech ARM XR Suction Cup — DEFIBTECH, L.L.C. · Class II
AutoPulse®Resuscitation System — ZOLL Circulation, Inc. · Class II
Defibtech ARM XR Stabilization Strap — DEFIBTECH, L.L.C. · Class II
ROSC-U System — Resuscitation International · Class II
ROSC-U Wheeled/Storage Case — Resuscitation International · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Resuscitation International

Sources (1)

FDA UDI e6aa0000-2ea7-4756-ae47-b258d00b7afa 34 fields · synced May 31, 2026