Gossen Metrawatt SECULIFE

FDA UDI

Class II (US FDA UDI)

by Bc Group International, Inc.

Identity

Trade Name: Gossen Metrawatt SECULIFE FDA UDI
Generic Name: External defibrillator tester FDA UDI
Device Name: Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt FDA UDI
Model / Reference: DF Base FDA UDI
Description: Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt FDA UDI

Identifiers

Catalog Number: M695Q FDA UDI
Primary DI / UDI-DI: 00863313000354 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

Gossen Metrawatt SECULIFE by Bc Group International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External defibrillator tester.

Datrend — Datrend Systems, Inc. · Class II
Defibrillator / Transcutaneous Pacemaker Analyzer — Netech Corp. · Class II
Impulse 7000DP — FLUKE ELECTRONICS CORPORATION · Class II
Impulse 7010 — FLUKE ELECTRONICS CORPORATION · Class II
Impulse 6000D — FLUKE ELECTRONICS CORPORATION · Class II
SigmaPace 1000 — FLUKE ELECTRONICS CORPORATION · Class II
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

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

Manufacturer

Manufacturer: Bc Group International, Inc.

Sources (1)

FDA UDI 5b916e4a-9fd2-4838-a343-a0cd03420d40 36 fields · synced May 30, 2026