Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX

GUDID 03701354407701

Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series with double operating channel

PLASMABIOTICS

Endoscope clean-storage system

• Primary Device ID: 03701354407701
• NIH Device Record Key: 952d2cdd-7669-49ea-9051-dff51072853a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
• Version Model Number: PW90 2C-G-D
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701354407701 [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: 2021-05-24
• Device Publish Date: 2021-05-14

On-Brand Devices [Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX ]

• 03701354402201: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 serie
• 03701354407701: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 serie