Medfusion

GUDID 10610586041525

SMITHS MEDICAL MD, INC.

Infusion pump medication-dosage application software

• Primary Device ID: 10610586041525
• NIH Device Record Key: e8820ac5-d7bb-4132-96d9-fcabd48da3c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medfusion
• Version Model Number: 22-4095-0200-51
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	10610586041525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111386

FDA Product Code

• MRZ: ACCESSORIES, PUMP, INFUSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-11-16

On-Brand Devices [Medfusion]

• 00610586032595: MFCC1
• 00610586032335: 22-3510-51
• 15019517130928: 67-2586-0100-01 is an electronic file. There is no packaging.
• 15019517070996: 4000-0106-231
• 15019517070750: 4000-0106-00
• 15019517069624: 4000-0106-01
• 15019517047509: 67-2450-010501-51
• 15019517047493: 67-2451-010501-51
• 10610586031816: 3000RS232
• 10610586031489: 22-1000-51
• 10610586043611: 67-2450-0105-51
• 10610586042874: 67-2454-0300-51
• 10610586042867: 67-2449-0300-51
• 10610586042799: 67-2460-0003-51
• 10610586042423: 67-2477-0600-01
• 10610586041549: 67-2466-0200-51
• 10610586041525: 22-4095-0200-51
• 10610586040962: 22-4075-0300-51
• 10610586040658: 67-2467-0101-51
• 10610586040108: 22-4097-0101-51
• 10610586040092: 22-4095-0101-51
• 10610586039812: 22-4075-0201-51
• 10610586043581: 4000-0105-249
• 10610586043574: 4000-0105-78
• 10610586043567: 4000-0105-51
• 10610586043291: 3500-0600-51
• 10610586043017: 3500-0600-82
• 10610586041259: 3500-0600-00
• 10610586041242: 3500-0600-01
• 10610586040818: 4000-0101-51
• 10610586032318: 3500-500