Extension Set Regular Bore

GUDID 20853620005351

Merit Pharmaceutical

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• Primary Device ID: 20853620005351
• NIH Device Record Key: 33548e46-168d-404c-b4ab-b010ca568c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extension Set Regular Bore
• Version Model Number: 088713723000
• Company DUNS: 093370369
• Company Name: Merit Pharmaceutical
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com
• Phone: (323) 227-4831
• Email: solutions@meritpharm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853620005357 [Primary]
GS1	10853620005354 [Package]; Contains: 00853620005357; Package: [50 Units]; In Commercial Distribution
GS1	20853620005351 [Package]; Contains: 10853620005354; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162601

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2019-02-01
• Device Publish Date: 2019-01-01

Devices Manufactured by Merit Pharmaceutical

• 20853620005337 - IV Administration Set 60 Drop: 2020-05-04
• 10853620005439 - Needleless Neutral Valve: 2020-05-04
• 20853620005429 - IV Catheter Safety Winged 24G x 3/4: 2020-05-01
• 20853620005207 - IV Set With In-Line Filter: 2019-12-11
• 20853620005214 - IV Set: 2019-12-11
• 20853620005276 - IV Administration Set: 2019-12-11
• 00853620005302 - Pressure Infuser 1000mL: 2019-12-11
• 20853620005313 - IV Administration Set Needlefree: 2019-12-11