HeartMate Touch™ HMT2100

GUDID 05415067032065

Wireless Adapter

Thoratec Corporation

Medical networking interface unit

• Primary Device ID: 05415067032065
• NIH Device Record Key: 7c342150-97da-48f0-8300-2b156ea17998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartMate Touch™
• Version Model Number: HMT2100
• Catalog Number: HMT2100
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067032065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060040

FDA Product Code

• DSQ: Ventricular (assist) bypass

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: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [HeartMate Touch™]

• 05415067032065: Wireless Adapter
• 05415067032058: Communication System
• 05415067033758: Communication System