Smithworks Medical, Inc.

GUDID B96412VPK3L12

PAK2-P IV fluid warmer

Smithworks, Inc.

Intravenous fluid storage/warming bag

• Primary Device ID: B96412VPK3L12
• NIH Device Record Key: 251b26e3-0ad5-4bd5-a62b-a00864559603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smithworks Medical, Inc.
• Version Model Number: 12VPK3L12
• Company DUNS: 009796074
• Company Name: Smithworks, 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: 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
HIBCC	B96412VPK3L12 [Primary]

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [Smithworks Medical, Inc.]

• B964TSPI05: The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv
• B96412VSS3L02: Soft Sack IV fluid warmer
• B96412VPK3L12: PAK2-P IV fluid warmer