Passage® K12-00040

GUDID 10884450028411

Merit Medical Systems, Inc.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10884450028411
• NIH Device Record Key: ce881300-150c-49f2-9ba5-7fcc8827bce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passage®
• Version Model Number: 00884450028414
• Catalog Number: K12-00040
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450028414 [Primary]
GS1	10884450028411 [Package]; Contains: 00884450028414; Package: [50 Units]; In Commercial Distribution
GS1	20884450028418 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• OEQ: Angiography/angioplasty kit

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: 2018-10-15
• Device Publish Date: 2018-09-13

On-Brand Devices [Passage®]

• 10884450028411: 00884450028414
• 10884450019594: 00884450019597
• 20884450007185: 00884450007181
• 20884450589933: 00884450589939
• 20884450590106: 00884450590102
• 10884450834166: D
• 20884450834170: D