Altrix Temperature Management Wraps 8003-003-004

GUDID 57613327374327

STRYKER CORPORATION

Circulating-fluid whole-body heating/cooling system pad, single-use

• Primary Device ID: 57613327374327
• NIH Device Record Key: 73ff9163-e8b7-4294-86a6-e3a1f480265d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altrix Temperature Management Wraps
• Version Model Number: 8003-003-004
• Catalog Number: 8003-003-004
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327374322 [Primary]
GS1	57613327374327 [Package]; Contains: 07613327374322; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171149

FDA Product Code

• DWJ: System, thermal regulating

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: 2020-10-07
• Device Publish Date: 2020-09-29

On-Brand Devices [Altrix Temperature Management Wraps]

• 57613327374310: 8003-002-005
• 57613327374303: 8003-003-003
• 57613327374297: 8003-003-001
• 57613327374280: 8003-002-006
• 57613327374273: 8003-002-004
• 57613327374266: 8003-003-002
• 57613327374259: 8003-002-003
• 57613327374174: 8003-003-103
• 57613327374167: 8003-003-104
• 57613327374150: 3008-002-106
• 57613327374143: 8003-003-102
• 57613327374136: 8003-003-101
• 57613327374129: 8003-002-105
• 57613327374112: 8003-002-103
• 57613327374105: 8003-002-104
• 57613327374099: 8003-002-102
• 57613327374082: 8003-002-101
• 57613327374327: 8003-003-004
• 57613327374242: 8003-002-002