Bloom2 370344G

GUDID 00863019000368

Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator

Fischer Medical

Cardiac electrophysiology stimulation system

• Primary Device ID: 00863019000368
• NIH Device Record Key: 99798d7e-2be4-4560-982c-e5ec62ec22e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bloom2
• Version Model Number: Bloom2 Console
• Catalog Number: 370344G
• Company DUNS: 079978232
• Company Name: Fischer Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863019000368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173439

FDA Product Code

• JOQ: Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-03
• Device Publish Date: 2021-02-23

On-Brand Devices [Bloom2]

• 00863019000351: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
• 00863019000344: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
• 00863019000337: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
• 00863019000368: Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator