iCOR 01-06-9880-8

GUDID 29555342305757

FH W.Freeze FLEX AND SWIVEL

TELEFLEX INCORPORATED

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 29555342305757
• NIH Device Record Key: 955a4301-e8dc-4379-b357-67b4f02061b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCOR
• Version Model Number: IPN040598
• Catalog Number: 01-06-9880-8
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: 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: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	19555342305750 [Primary]
GS1	29555342305757 [Package]; Contains: 19555342305750; Package: Box [25 Units]; In Commercial Distribution
GS1	49555342305751 [Package]; Package: Case [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952823

FDA Product Code

• BYD: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [iCOR]

• 29555342305757: FH W.Freeze FLEX AND SWIVEL
• 29555342304255: Fa
• 49555342304204: Afa
• 29555342304194: Fsva
• 29555342304125: Fsv
• 49555342304020: AF
• 49555342303948: Filter F
• 29555342304262: FH WITH SOFT - FLEX AND SWIVEL
• 49555342304150: FH Soft
• 29555342304149: Fhsva
• 29555342304088: FHsv
• 29555342304064: AFHa
• 29555342304057: AFH
• 29555342304002: Fha
• 49555342303917: FH