EMP Burn Sheet Not Applicable

GUDID 00840155411876

Burn Sheet

MEDSOURCE INTERNATIONAL LLC

Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet Cotton burn sheet

• Primary Device ID: 00840155411876
• NIH Device Record Key: 7fb2ba01-2440-43ad-8a00-ea6999b70bd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMP Burn Sheet
• Version Model Number: EMP-7010
• 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: 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	00840155411852 [Primary]
GS1	00840155411876 [Package]; Contains: 00840155411852; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• FPY: Sheet, Burn

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: 2022-01-04
• Device Publish Date: 2021-12-27

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