MedSource Electrodes Not Applicable

GUDID 00816703028667

Electrodes, Adult, 25/pk - 24pk/cs

MEDSOURCE INTERNATIONAL LLC

External defibrillator electrode, adult, single-use

• Primary Device ID: 00816703028667
• NIH Device Record Key: 1db46614-4dda-4fd0-a2cf-e52e89913c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Electrodes
• Version Model Number: MS-65005-RCS
• 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	00816703028650 [Primary]
GS1	00816703028667 [Package]; Contains: 00816703028650; Package: Box [24 Units]; In Commercial Distribution
GS1	00816703028674 [Package]; Contains: 00816703028650; Package: Case [600 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-23
• Device Publish Date: 2021-07-15

On-Brand Devices [MedSource Electrodes]

• 00816703028667: Electrodes, Adult, 25/pk - 24pk/cs
• 00816703028636: Electrodes, Pediatric (25/pk - 24pks/cs)