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Auxiliary Water Tube

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
AUXILIARY WATER TUBE FDA UDI
Generic Name
Luminal device flushing tubing set, reusable FDA UDI
Device Name
MAJ-2021 AXILIARY WATER TUBE FOR TGF SCO FDA UDI
Model / Reference
MAJ-2021 FDA UDI
Description
MAJ-2021 AXILIARY WATER TUBE FOR TGF SCO FDA UDI

Identifiers

Primary DI / UDI-DI
04953170356223 FDA UDI
510(k) Number
K021886 FDA UDI
FDA Product Code
FDS 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luminal device flushing tubing set, reusable

Auxiliary Water Tube 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.

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 d21c39b4-7281-4ffb-9eb3-2e14ee7ce4c4 35 fields · synced May 29, 2026