PharmGuard

GUDID 15019517197112

Smiths Medical ASD, Inc.

Infusion pump medication-dosage application software

• Primary Device ID: 15019517197112
• NIH Device Record Key: 1e44ce88-724e-4b63-8893-20371431e295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PharmGuard
• Version Model Number: 21-2194-0403-25
• 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	15019517197112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170982

FDA Product Code

• MEA: Pump, infusion, pca

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: 2020-02-04
• Device Publish Date: 2020-01-27

On-Brand Devices [PharmGuard]

• 15019517157888: 22-0117-0201-25
• 15019517157871: 22-0004-0204-25
• 15019517088632: 22-4095-0204-25
• 15019517151107: 22-4075-0301-51
• 15019517197112: 21-2194-0403-25
• 15019517177381: 22-0004-0205-25
• 15019517177374: 22-0117-0202-25
• 15019517177367: 22-4095-0205-25
• 15019517225495: 22-4095-0206-25
• 15019517225488: 22-0117-0203-25
• 15019517225471: 22-0004-0206-25