Autoclavable version of PW Enew

GUDID 03701354402515

Autoclavable version of PW Enew

PLASMABIOTICS

Endoscope clean-storage system

• Primary Device ID: 03701354402515
• NIH Device Record Key: 68e0f279-ce3f-4c27-9ed3-3ff3d893086a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autoclavable version of PW Enew
• Version Model Number: PW Enew/A
• Company DUNS: 262972663
• Company Name: PLASMABIOTICS
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter
• Length: 34 Centimeter
• Width: 23 Centimeter
• Height: 3 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.9 Inches of Mercury and 1.1 Inches of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701354402515 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2021-05-21
• Device Publish Date: 2021-05-13

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