Bloom2

FDA UDI

Class II (US FDA UDI)

by Fischer Medical

Identity

Trade Name: Bloom2 FDA UDI
Generic Name: Cardiac electrophysiology stimulation system FDA UDI
Device Name: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator FDA UDI
Model / Reference: Bloom2 Console FDA UDI
Description: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator FDA UDI

Identifiers

Catalog Number: 370344G FDA UDI
Primary DI / UDI-DI: 00863019000368 FDA UDI
510(k) Number: K173439 FDA UDI
FDA Product Code: JOQ FDA UDI
GMDN Term: Cardiac electrophysiology stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1750 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 electrophysiology stimulation system

Bloom2 by Fischer Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac electrophysiology stimulation system.

StimLab — MICROPACE PTY LIMITED · Class II
Micropace — MICROPACE PTY LIMITED · Class II
EP-4™ — ST. JUDE MEDICAL, INC. · Class II
EP-4™ — ST. JUDE MEDICAL, INC. · Class II
EP-4™ — ST. JUDE MEDICAL, INC. · Class II
EP-4™ — ST. JUDE MEDICAL, INC. · Class II
ORLAB — MICROPACE PTY LIMITED · Class II
EP-4™ — ST. JUDE MEDICAL, INC. · Class II

Cleared under the same submission

K173439 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: Fischer Medical

Sources (1)

FDA UDI 99798d7e-2be4-4560-982c-e5ec62ec22e9 35 fields · synced May 30, 2026