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Maintenance Unit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
MAINTENANCE UNIT FDA UDI
Generic Name
Invasive medical device leak tester, electrical FDA UDI
Device Name
"MU-1 MAINTENANCE UNIT - NO CONTAINERS" FDA UDI
Model / Reference
MU-1 FDA UDI
Description
"MU-1 MAINTENANCE UNIT - NO CONTAINERS" FDA UDI

Identifiers

Primary DI / UDI-DI
04953170060427 FDA UDI
FDA Product Code
FDF FDA UDI
NWB FDA UDI
GMDN Term
Invasive medical device leak tester, electrical 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: Invasive medical device leak tester, electrical

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

Similar devices

Also classified as Invasive medical device leak tester, electrical.

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 51cb7c4e-bd1a-4c1f-89ad-024cfec48dd3 34 fields · synced Jun 8, 2026