basixSKY™ SKY1302

GUDID 00884450822517

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00884450822517
• NIH Device Record Key: fe31e405-8d91-4e96-8766-ec6574548e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: basixSKY™
• Version Model Number: Initial Release
• Catalog Number: SKY1302
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• 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	00884450822517 [Unit of Use]
GS1	10884450822514 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

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: 2025-01-06
• Device Publish Date: 2024-12-28

On-Brand Devices [basixSKY™]

• 00884450812952: Initial Release
• 00884450822500: Initial Release
• 00884450822524: Initial Release
• 00884450822517: Initial Release