EMP Burn Sheet Not Applicable

GUDID 00840155411876

Burn Sheet

MEDSOURCE INTERNATIONAL LLC

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