Therm-X TX0101

GUDID 00850001096065

Therm-X Shoulder Garment

ZENITH TECHNICAL INNOVATIONS, LLC

Inflatable hot/cold therapy pack/electric pump

• Primary Device ID: 00850001096065
• NIH Device Record Key: bcf0aba5-d0a7-482b-b78c-0b9322239dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Therm-X
• Version Model Number: Therm-X Shoulder Garment
• Catalog Number: TX0101
• Company DUNS: 062931546
• Company Name: ZENITH TECHNICAL INNOVATIONS, LLC
• 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: false
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001096065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181149

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-22
• Device Publish Date: 2018-09-17

On-Brand Devices [Therm-X]

• 00850001096089: Therm-X Foot DVT Garment
• 00850001096072: Therm-X Calf DVT Garment
• 00850001096065: Therm-X Shoulder Garment
• 00850001096058: Therm-X Elbow Garment
• 00850001096041: Therm-X Ankle Garment
• 00850001096034: Therm-X Knee Garment
• 00850001096027: Therm-X Back Garment
• 00850001096010: Therm-X AT
• 00850001096003: Therm-X Pro
• 00850001096164: Therm-X Split Umbilical Hose
• 00850001096096: Therm-X Umbilical Hose
• 00850001096171: Therm-X Hip Garment
• 00850001096232: Therm-X Back SPU
• 00850001096225: Therm-X Hip SPU
• 00850001096218: Therm-X Ankle SPU
• 00850001096201: Therm-X Knee SPU
• 00850001096195: Therm-X Shoulder SPU
• 00850001096188: Therm-X HOME
• 00850001096157: Therm-X Power Supply and Cord (Medical Grade)
• 00850001096270: Therm-X Extender Straps
• 00850001096256: Therm-X Disposable Calf DVT Garment
• 00850001096294: Therm-X AT
• 00850001096287: Therm-X HOME
• 00850001096300: Therm-X XL Shoulder Garment
• 00850001096348: Therm-X Half-Leg (Lower Leg) Garment
• 00850001096379: Therm-X Butterfly Knee Small, SPU
• 00850001096362: Therm-X Butterfly Knee Large, SPU
• 00850001096355: Therm-X Hand Garment
• 00850001096324: Therm-X Hand SPU