Elite Stethoscope Not Applicable

GUDID 00816703023204

Elite Dual-Head Steth, Black, Elite First Aid Part Number: 601

MEDSOURCE INTERNATIONAL LLC

Mechanical stethoscope

• Primary Device ID: 00816703023204
• NIH Device Record Key: 5aeb7356-f8f4-4361-956a-15dfaa267daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Stethoscope
• Version Model Number: ELITE-70031
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703023198 [Primary]
GS1	00816703023204 [Package]; Contains: 00816703023198; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• LDE: Stethoscope, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-29
• Device Publish Date: 2021-04-20

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

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• 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