Smith's Catheters Not Applicable

GUDID 00840155411159

Truesafe Comfort (PUR Catheter), 18G x 1.88"

MEDSOURCE INTERNATIONAL LLC

Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector Intravenous line recessed-needle connector

• Primary Device ID: 00840155411159
• NIH Device Record Key: 472ac374-4dbc-4fa9-ba03-47b04a568069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smith's Catheters
• Version Model Number: SM-84318
• 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	00840155411142 [Primary]
GS1	00840155411159 [Package]; Contains: 00840155411142; Package: Box [50 Units]; In Commercial Distribution
GS1	00840155411166 [Package]; Contains: 00840155411142; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161779

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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: 2021-08-23
• Device Publish Date: 2021-08-13