Kelvi

GUDID 00850001185110

Kelvi Hip Pro Smart Wrap, Right

HYPOTHERMIA DEVICES, INC.

Circulating-fluid localized thermal therapy system

• Primary Device ID: 00850001185110
• NIH Device Record Key: d4901dd0-fd5a-4a7f-814d-b79ea6bad4eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kelvi
• Version Model Number: KLV20009
• Company DUNS: 079330735
• Company Name: HYPOTHERMIA DEVICES, 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: false
• Lot Batch: true
• 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

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001185110 [Primary]

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: 2024-01-24
• Device Publish Date: 2024-01-16

On-Brand Devices [Kelvi]

• 00850001185059: Kelvi Ankle Pro Smart Wrap
• 00850001185042: Kelvi Knee Pro Smart Wrap
• 00850001185035: Kelvi Back Pro Smart Wrap
• 00850001185028: Kelvi Shoulder Pro Smart Wrap
• 00850001185011: Kelvi Pro Umbilical
• 00850001185004: Kelvi Pro Console
• 00850001185073: Kelvi Hand Station
• 00850001185110: Kelvi Hip Pro Smart Wrap, Right
• 00850001185103: Kelvi Hip Pro Smart Wrap, Left