MedSource Extension Set Not Applicable

GUDID 00840155412323

360" Coiled Extension Set

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00840155412323
• NIH Device Record Key: c39618c5-645e-4645-827e-6286b8d1636e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Extension Set
• Version Model Number: IT0360-PL
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840155412316 [Primary]
GS1	00840155412323 [Package]; Contains: 00840155412316; Package: Box [20 Units]; In Commercial Distribution
GS1	00840155412330 [Package]; Contains: 00840155412316; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120424

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2022-02-04
• Device Publish Date: 2022-01-27

On-Brand Devices [MedSource Extension Set]

• 00840155412323: 360" Coiled Extension Set
• 00840155412484: MedSource 360 inch Coiled Extension Set
• 00840155412453: IV Extension Set, 6 inch, T-Port