BALLOON CONTROL UNIT

GUDID 04953170237461

"OBCU OLYMPUS BALLOON CONTROL UNIT (120V)"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic control/video-imaging system Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable Catheter/overtube balloon inflator, reusable

• Primary Device ID: 04953170237461
• NIH Device Record Key: 96190a73-bb1b-46ab-9771-576ccac9b428
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALLOON CONTROL UNIT
• Version Model Number: OBCU
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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(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	04953170237461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071254

FDA Product Code

• FDA: Enteroscope and accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [BALLOON CONTROL UNIT]

• 04953170239533: OBCU
• 04953170237461: "OBCU OLYMPUS BALLOON CONTROL UNIT (120V)"