ComforTen® Multiple Skin Test System 80000000021

GUDID 10365044000018

Multiple skin test system with 10 testing legs/tines

Jubilant Hollisterstier LLC

Allergy testing lancet

• Primary Device ID: 10365044000018
• NIH Device Record Key: d0ce37c1-8b4a-44f3-87ae-08109f68b7cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComforTen® Multiple Skin Test System
• Version Model Number: 80000000021
• Catalog Number: 80000000021
• Company DUNS: 119241112
• Company Name: Jubilant Hollisterstier LLC
• Device Count: 3
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365044000011 [Primary]
GS1	10365044000018 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953939

FDA Product Code

• LDH: System, Delivery, Allergen And Vaccine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-25
• Device Publish Date: 2024-11-15

Devices Manufactured by Jubilant Hollisterstier LLC

• 10365044000001 - Quintest® Multiple Skin Test Device: 2024-11-25 Multiple skin test system with 5 testing legs/tines
• 10365044000018 - ComforTen® Multiple Skin Test System: 2024-11-25Multiple skin test system with 10 testing legs/tines
• 10365044000018 - ComforTen® Multiple Skin Test System: 2024-11-25 Multiple skin test system with 10 testing legs/tines
• 10365044000025 - Quintip® Skin Test Device: 2024-11-25 Disposable self loading test system with 1 testing leg/tine
• 10365044000032 - Prick Lancetter™: 2024-11-25 1 testing leg/tine
• 10365044000049 - Skin Test Reservoirs: 2024-11-25 Holds testing antigens
• 00365044000059 - ComforTen® 30-hole covered tray: 2024-11-25 30 hole test tray
• 00365044000066 - ComforTen® 60-hole covered tray: 2024-11-25 60 hole test tray
• 00365044000073 - Quintest® Covered Tray: 2024-11-25 60 hole covered test tray