T/Pump

GUDID 00850007350130

T/pump Professional

C2DX, INC.

Circulating-fluid thermal therapy system pack, reusable

• Primary Device ID: 00850007350130
• NIH Device Record Key: 47280c89-4e1b-4f5d-acc8-32d837b37106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T/Pump
• Version Model Number: TP700
• Company DUNS: 116981210
• Company Name: C2DX, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
GS1	00850007350130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073675

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

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: 2022-05-11
• Device Publish Date: 2022-05-03

On-Brand Devices [T/Pump]

• 00850007350147: T/pump Professional
• 00850007350130: T/pump Professional