ProCuity 3009PX-L-300

GUDID 07613327652154

ProCuity L + IsoFlex

STRYKER CORPORATION

Basic electric hospital bed

• Primary Device ID: 07613327652154
• NIH Device Record Key: f9b3661f-2c9f-4772-9160-73ec2fc6fc6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCuity
• Version Model Number: 3009PX-L-300
• Catalog Number: 3009PX-L-300
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• 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 Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327652154 [Primary]

FDA Product Code

• FNL: BED, AC-POWERED ADJUSTABLE HOSPITAL

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: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [ProCuity]

• 07613327523942: 300900000100
• 07613327512656: 300900000000
• 07613327541236: ProCuity LEX + IsoTour Premium
• 07613327541229: ProCuity LEX + IsoTour Std
• 07613327541212: ProCuity LEX + IsoAir & Pump
• 07613327541205: ProCuity LE + IsoAir & Pump
• 07613327541199: ProCuity L + Comfort Gel
• 07613327541182: ProCuity LE + IsoTour Std
• 07613327541175: ProCuity LE + IsoTour Premium
• 07613327541168: ProCuity L + ProForm
• 07613327541311: ProCuity ZM + Isolibrium
• 07613327652239: ProCuity ZX + IsoFlex
• 07613327652222: ProCuity Z + IsoFlex
• 07613327652215: ProCuity LEX + IsoFlex
• 07613327652192: ProCuity LEX + ComfortGel
• 07613327652178: ProCuity LE + ComfortGel
• 07613327652161: ProCuity LE + IsoFlex
• 07613327652154: ProCuity L + IsoFlex