BEERE MEDICAL CS-15422-VFIE

GUDID 20801902112822

Arrow-Clark(TM) VectorFlow(TM) Antegrade Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to Cuff: 42 cm

TELEFLEX INCORPORATED

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 20801902112822
• NIH Device Record Key: 147b9e7f-e51e-4192-96ef-f3da2861a0ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEERE MEDICAL
• Version Model Number: IPN001174
• Catalog Number: CS-15422-VFIE
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10801902112825 [Primary]
GS1	20801902112822 [Package]; Contains: 30801902112829; Package: Case [1 Units]; Discontinued: 2018-10-24; Not in Commercial Distribution
GS1	30801902112829 [Package]; Contains: 10801902112825; Package: Box [1 Units]; Discontinued: 2018-10-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141051

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-04-20

Devices Manufactured by TELEFLEX INCORPORATED

• 20801902221661 - ARROW: 2024-12-26 Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC Kit pre-loaded with Arrow(R) VPS Precision(TM) Stylet
• 20801902221678 - ARROW: 2024-12-26 Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC Kit pre-loaded with Arrow(R) VPS Precision(TM) Stylet
• 20801902220312 - ARROW: 2024-12-16 UNIVERSAL ACCESS KIT
• 20801902221609 - ARROW: 2024-12-16 Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included)
• 20801902221616 - ARROW: 2024-12-16 Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC Set
• 25060112317518 - LMA AIRWAY MANAGEMENT: 2024-12-13 LMA Gastro Cuff Pilot Size 3
• 25060112317525 - LMA AIRWAY MANAGEMENT: 2024-12-13 LMA Gastro Cuff Pilot Size 4
• 25060112317532 - LMA AIRWAY MANAGEMENT: 2024-12-13 LMA Gastro Cuff Pilot Size 5