DISPOSABLE BALLOON CATHETER N6193431

GUDID 14953170463683

OLYMPUS MEDICAL SYSTEMS CORP.

Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter Gastrointestinal/tracheobronchial balloon catheter

• Primary Device ID: 14953170463683
• NIH Device Record Key: 9952bb36-557a-4ba3-99a2-0662f8bd9b08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE BALLOON CATHETER
• Version Model Number: B7-2LA
• Catalog Number: N6193431
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170463686 [Primary]
GS1	14953170463683 [Package]; Contains: 04953170463686; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962925

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [DISPOSABLE BALLOON CATHETER]

• 14953170047487: DISPOSABLE BALLOON CATHETER
• 14953170047463: B7-2C
• 14953170047449: DISPOSABLE BALLOON CATHETER
• 14953170047395: DISPOSABLE BALLOON CATHETER
• 14953170047371: DISPOSABLE BALLOON CATHETER
• 14953170463751: B5-2Q
• 14953170463706: B7-2Q
• 14953170463683: B7-2LA