Bloom

GUDID 00863019000320

Fischer Medical

External pacemaker, epicardial pacing

• Primary Device ID: 00863019000320
• NIH Device Record Key: 5e673e72-8f2b-4107-801c-1aa45290f870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bloom
• Version Model Number: 108419G-2
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863019000320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991293

FDA Product Code

• JOQ: Generator, Pulse, Pacemaker, External Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-05
• Device Publish Date: 2016-09-12

On-Brand Devices [Bloom]

• 00863019000320: 108419G-2
• 00863019000313: 106459G
• 00863019000306: 206276G