Medfusion

GUDID 10610586043307

Smiths Medical ASD, Inc.

Syringe pump

• Primary Device ID: 10610586043307
• NIH Device Record Key: 3b6a94aa-ff52-44a7-9d7f-54c49e343291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medfusion
• Version Model Number: 3500-0600-78
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610586043307 [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: 2022-04-06
• Device Publish Date: 2022-03-29

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