SoloPace Fusion Kit Shipping Case

GUDID 20850056280055

Shipping case

SOLO PACE INC.

External pacemaker, epicardial pacing

• Primary Device ID: 20850056280055
• NIH Device Record Key: 19f92e9a-d547-4949-97cb-acfb2b4ee43a
• Commercial Distribution Discontinuation: 2026-02-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SoloPace Fusion Kit Shipping Case
• Version Model Number: SOLOFUSE1
• 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	20850056280055 [Primary]

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

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
• 00850056280051 - SoloPace Fusion Kit: 2026-02-13
• 20850056280055 - SoloPace Fusion Kit Shipping Case: 2026-02-13Shipping case
• 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