MEDFUSION

GUDID 15019517154320

Smiths Medical ASD, Inc.

Syringe pump

• Primary Device ID: 15019517154320
• NIH Device Record Key: c2bb0c07-7bf1-4014-b599-33ee1fbbe62e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDFUSION
• Version Model Number: 4000-0107-231
• 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	15019517154320 [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: 2019-09-26
• Device Publish Date: 2019-09-18

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