Medfusion

GUDID 15019517328622

Smiths Medical ASD, Inc.

Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump

• Primary Device ID: 15019517328622
• NIH Device Record Key: e19e213d-7941-441e-95d7-48186bf927d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medfusion
• Version Model Number: 22-0000-03
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, Inc.
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517328622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111386

FDA Product Code

• FRN: Pump, infusion

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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [Medfusion]

• 15019517178067: 22-4002
• 15019517154320: 4000-0107-231
• 15019517154313: 4000-0107-01
• 15019517154306: 4000-0107-00
• 15019517155167: 67-2451-010700-01
• 15019517155150: 67-2450-010700-01
• 15019517155143: 67-2391-010700-01
• 10610586043307: 3500-0600-78
• 15019517328622: 22-0000-03