ULTRA GI Process Challenge Device (PCD) Vial

GUDID 20705037069368

ULTRA GI Cycle Process Challenge Device Vial

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Biological sterilization indicator

• Primary Device ID: 20705037069368
• NIH Device Record Key: 99e80732-43b7-4f91-be87-7cc2d8696ffc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA GI Process Challenge Device (PCD) Vial
• Version Model Number: 43400
• 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: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705037069368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234084

FDA Product Code

• FRC: Indicator, biological sterilization process

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: 2024-10-03
• Device Publish Date: 2024-09-25

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

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• 10705037068432 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle: 2024-10-03 Plasma Sterilizer
• 10705037069583 - ULTRA GI Cycle Validation Kit: 2024-10-03 STERRAD 100NX System ULTRA GI Cycle Validation Kit
• 20705037069368 - ULTRA GI Process Challenge Device (PCD) Vial: 2024-10-03ULTRA GI Cycle Process Challenge Device Vial
• 20705037069368 - ULTRA GI Process Challenge Device (PCD) Vial: 2024-10-03 ULTRA GI Cycle Process Challenge Device Vial
• 10705037069316 - Evotech: 2024-06-28 Channel Connector Tube, Orange
• 10705037068685 - Evotech: 2024-02-23 Channel Separator, PNTX
• 10705037069309 - Evotech: 2024-02-23 Channel Connector Tube, Brown