PharmGuard 21-2194-0402-25

GUDID 15019517081275

SMITHS MEDICAL MD, INC.

Infusion pump medication-dosage application software

• Primary Device ID: 15019517081275
• NIH Device Record Key: 0c3100e7-9f2d-4607-acd6-f249d66fa974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PharmGuard
• Version Model Number: 2194
• Catalog Number: 21-2194-0402-25
• 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: 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	15019517081275 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-09-21

On-Brand Devices [PharmGuard]

• 15019517081282: 2193
• 15019517081275: 2194