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Balloon Control Unit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
BALLOON CONTROL UNIT FDA UDI
Generic Name
Catheter/overtube balloon inflator, reusable FDA UDI
Device Name
"OBCU OLYMPUS BALLOON CONTROL UNIT (120V)" FDA UDI
Model / Reference
OBCU FDA UDI
Description
"OBCU OLYMPUS BALLOON CONTROL UNIT (120V)" FDA UDI

Identifiers

Primary DI / UDI-DI
04953170237461 FDA UDI
FDA Product Code
FDA FDA UDI
NWB FDA UDI
FED FDA UDI
GMDN Term
Catheter/overtube balloon inflator, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Catheter/overtube balloon inflator, reusable

Balloon Control Unit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 96190a73-bb1b-46ab-9771-576ccac9b428 34 fields · synced May 29, 2026