BC Biomedical Defibrillator Analyzer

FDA UDI

Class II (US FDA UDI)

by Bc Group International, Inc.

Identity

Trade Name: BC Biomedical Defibrillator Analyzer FDA UDI
Generic Name: External defibrillator tester FDA UDI
Device Name: Defibrillator Analyzer, without Transcutaneous Pacemaker Input FDA UDI
Model / Reference: DA-2006 FDA UDI
Description: Defibrillator Analyzer, without Transcutaneous Pacemaker Input FDA UDI

Identifiers

Catalog Number: DA-2006 FDA UDI
Primary DI / UDI-DI: 00863313000309 FDA UDI
510(k) Number: K110192 FDA UDI
FDA Product Code: DRL FDA UDI
GMDN Term: External defibrillator tester FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5325 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

FDA UDI

Category: External defibrillator tester

BC Biomedical Defibrillator Analyzer by Bc Group International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Impulse 6000D — FLUKE ELECTRONICS CORPORATION · Class II
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Defibrillator Analyzer — Netech Corp. · Class II
Impulse 4000 — FLUKE ELECTRONICS CORPORATION · Class II

Cleared under the same submission

K110192 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: Bc Group International, Inc.

Sources (1)

FDA UDI 13c097b7-c7ff-4980-a94f-0900216d3888 36 fields · synced May 30, 2026