SoloPace Fusion Sterile Pack

GUDID 00850056280044

SOLO PACE INC.

External pacemaker, epicardial pacing

• Primary Device ID: 00850056280044
• NIH Device Record Key: e18c4429-e92e-443a-8f3a-cf55b40fd947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoloPace Fusion Sterile Pack
• Version Model Number: K12-12621
• Company DUNS: 138344845
• Company Name: SOLO PACE INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00850056280044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252674

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2026-02-13
• Device Publish Date: 2026-02-05

Devices Manufactured by SOLO PACE INC.

• 00850056280006 - SoloPace Fusion Ground Pad: 2026-02-13
• 00850056280044 - SoloPace Fusion Sterile Pack: 2026-02-13
• 00850056280044 - SoloPace Fusion Sterile Pack: 2026-02-13
• 00850056280051 - SoloPace Fusion Kit: 2026-02-13
• 20850056280055 - SoloPace Fusion Kit Shipping Case: 2026-02-13 Shipping case
• 00850056280020 - SoloPace EPG: 2026-02-10
• 00850056280013 - Solo Pace Control System: 2025-01-31 Solo Pace Control System Remote Control Module
• 00850056280037 - Solo Pace Control System: 2025-01-31 Solo Pace Control External Pulse Generator