Balloon2

GUDID 04953170053870

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex

• Primary Device ID: 04953170053870
• NIH Device Record Key: ee781c8f-f4eb-4c0c-a429-03f48179cb1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon2
• Version Model Number: MH-303
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 20
• 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: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170053870 [Primary]
GS1	84953170053876 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926514

FDA Product Code

• FDT: Duodenoscope and accessories, flexible/rigid

Sterilization

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

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

[04953170053870]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-06

On-Brand Devices [Balloon2]

• 04953170355745: MH-525
• 04953170355738: MH-304
• 04953170355721: MH-303
• 04953170055546: MH-525
• 04953170053870: MH-303