Evotech 102902

GUDID 10705037044979

Conn-Biopsy-Olympus

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope assembly adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor Endoscope channel-opening adaptor

• Primary Device ID: 10705037044979
• NIH Device Record Key: 7adeb5c0-f999-4a88-8dc9-efce6d545d0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evotech
• Version Model Number: 102902
• Catalog Number: 102902
• 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: true
• Serial Number: false
• 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: true

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037044979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082392

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: 4
• Public Version Date: 2020-12-11
• Device Publish Date: 2016-09-24

On-Brand Devices [Evotech]

• 10705037031092: Evotech ECR - GI Chem Kit
• 10705037049547: Channel Connector Tube, Brown
• 10705037049530: Channel Connector Tube, Leak Tester
• 10705037049523: Channel Connector Tube, Yellow
• 10705037049516: Channel Connector Tube, Leak Tester
• 10705037049509: Connector Tube, Yellow
• 10705037049493: Channel Separator, Olympus
• 10705037049486: Channel Connector Tube, Clear
• 10705037049479: Channel Connector Tube, Leak Tester, HSW
• 10705037049462: Connector Tube, White
• 10705037049455: Channel Connector Tube, Brown
• 10705037049448: Channel Connector Tube, Yellow
• 10705037049431: Channel Connector Tube, Yellow
• 10705037049424: Channel Connector Tube, Yellow
• 10705037049417: Channel Connector Tube, Orange
• 10705037048779: Channel Connector Tube - Yellow
• 10705037048526: Plug-S Valve HSG-PNTx
• 10705037048519: Adapter-Water/Air-PNTX
• 10705037048502: Plug, S Valve HSG, PNTX OF-B65 SS
• 10705037048496: Adapter WTRJT Connector
• 10705037048489: Channel Separator, PNTX
• 10705037048465: Channel Connector Tube
• 10705037048441: Channel Separator, PNTX
• 10705037048434: Channel Separator, KARL STORZ
• 10705037048427: Channel Separator, Olympus
• 10705037048403: Channel Connector Tube, Orange
• 10705037048397: Conne Tube Dbl Water
• 10705037048182: Channel Connector Tube, Blue
• 10705037048175: Channel Plug, Pentax
• 10705037048168: Channel Connector T-Org- DB-HLD
• 10705037048151: Channel Connector Tube - Orange
• 10705037048120: Channel Plug
• 10705037047826: Connector Tube, Brown
• 10705037047819: Channel Separator, Olympus
• 10705037047802: Channel Connector Tube, Brown
• 10705037047789: Channel Connector Tube, Green
• 10705037047666: Channel Connector Tube - Yellow
• 10705037045068: Channel Separator Olympu
• 10705037045051: Chann. Conn. Tube Orange
• 10705037045044: Channel Connector Tuber - Orange
• 10705037045037: Channel Connector Tube, Leak Tester
• 10705037045006: Channel Connector Tube Brown
• 10705037044993: Channel Connector Tube Lk Tester
• 10705037044986: Channel Connector Tube Orange
• 10705037044979: Conn-Biopsy-Olympus
• 10705037044962: Channel Connector Tube Brown
• 10705037031016: EVOTECH Equipment Kit
• 10705037030958: Endoscope Cleaner and Reprocessor (ECR)
• 10705037013654: Adapter WTRJT-IRR Tube
• 10705037013586: Suction Channel plug Olympus LF-1