MedSource Sharps Dart 24/case

GUDID 00816703021392

Sharps Dart 24/case

MEDSOURCE INTERNATIONAL LLC

Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container

• Primary Device ID: 00816703021392
• NIH Device Record Key: b6aa29aa-d14e-4407-b407-a4ac93a154f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Sharps Dart 24/case
• Version Model Number: MS-64250
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703021392 [Primary]
GS1	00840155411616 [Package]; Package: Master Case [192 Units]; In Commercial Distribution
GS1	10816703021399 [Package]; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150333

FDA Product Code

• MMK: Container, Sharps

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-14

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

• 00840155401419 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 14Gx1.25
• 00840155406179 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 16Gx1.25
• 00840155413870 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1.25
• 00840155413900 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 22Gx1
• 00840155413931 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 24Gx0.75
• 00840155413962 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
• 00840155413993 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
• 00840155414020 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 16g x1.25 pur, winged