ASP AEROFLEX 28000

GUDID 10705037048717

Automatic Endoscope Reprocessor

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Endoscope washer-disinfector (chemical)

• Primary Device ID: 10705037048717
• NIH Device Record Key: 38c269af-fee0-4054-a7f6-af8925fac0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASP AEROFLEX
• Version Model Number: 28000
• Catalog Number: 28000
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: true

Customer Support Contacts

• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037048717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181472

FDA Product Code

• FEB: Accessories, cleaning, for endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-16
• Device Publish Date: 2019-07-31

On-Brand Devices [ASP AEROFLEX]

• 10705037065370: Elevator Pressure Relief Connection Tube
• 10705037064717: Elevator Connection Tube
• 10705037064700: Suction Connection Tube
• 10705037064694: Configurable Connection Tube
• 10705037064687: Luer Fitting Connection Tube
• 10705037064670: Leak Tester Connection Tube
• 10705037064649: Pressure Relief Connection Tube
• 10705037068753: Connector Tube, Large Diameter, Luer
• 10705037067145: Connector Tube
• 10705037048717: Automatic Endoscope Reprocessor