MedSource Electrodes (3/pk - 200pks/cs)

GUDID 00816703021316

Electrodes (3/pk - 200pks/cs)

MEDSOURCE INTERNATIONAL LLC

Electrocardiographic electrode, single-use

• Primary Device ID: 00816703021316
• NIH Device Record Key: 72ae3b4b-4e78-4829-a2d7-b920fbfbfe4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Electrodes (3/pk - 200pks/cs)
• Version Model Number: MS-65003
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703021316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093327

FDA Product Code

• DRX: Electrode, Electrocardiograph

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