ThermaSolutions

GUDID 00851450007268

THERMASOLUTIONS, INC.

Intraperitoneal-circulation hypothermia system administration kit

• Primary Device ID: 00851450007268
• NIH Device Record Key: 1c67a18c-e702-4a33-9953-a0dc0ef3364f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermaSolutions
• Version Model Number: FLW-0010
• Company DUNS: 186855925
• Company Name: THERMASOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00851450007268 [Primary]

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [ThermaSolutions ]

• 00851450007121: Temperature probe-pouch with two TMP-1304
• 00851450007114: Temperature probe-single TMP-1304
• 00851450007305: FLW-0120
• 00851450007268: FLW-0010
• 00851450007244: PAK-0112
• 00851450007237: FLW-0111