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Water-resistant Cap

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Water-resistant Cap FDA UDI
Generic Name
Luminal device flushing tubing set, reusable FDA UDI
Model / Reference
MAJ-896 FDA UDI

Identifiers

Primary DI / UDI-DI
04953170062971 FDA UDI
510(k) Number
K051541 FDA UDI
FDA Product Code
FDF FDA UDI
ITX FDA UDI
GMDN Term
Luminal device flushing tubing set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1570 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Luminal device flushing tubing set, reusable

Water-resistant Cap by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luminal device flushing tubing set, reusable.

Cleared under the same submission

K051541 also covers:

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 8c550696-0a66-4dde-881f-7f1d461ef643 34 fields · synced Jun 1, 2026