Smithworks Medical, Inc.

GUDID B964TSPI05

The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal maintenance tool. The TSPI employs chemical hot packs to maintain target temperatures for up to an hour after deployment. There are no electronics within this device.

Smithworks, Inc.

Personal device holder, reusable

• Primary Device ID: B964TSPI05
• NIH Device Record Key: 31809b58-edba-4509-ada8-9f2e193cd015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smithworks Medical, Inc.
• Version Model Number: TSPI05
• 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	B964TSPI05 [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