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CeroFrict

FDA UDI

Class II (US FDA UDI)

by SML Med-Tech Solutions Limited

Identity

Trade Name
CeroFrict FDA UDI
Generic Name
Endoscope air/water valve, single-use FDA UDI
Device Name
Disposable Endoscope Valve Sets FDA UDI
Model / Reference
SML001-PT FDA UDI
Description
Disposable Endoscope Valve Sets FDA UDI

Identifiers

Primary DI / UDI-DI
04897129990420 FDA UDI
510(k) Number
K220884 FDA UDI
FDA Product Code
ODC FDA UDI
GMDN Term
Endoscope air/water valve, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope channel support kitEndoscope suction valve, single-useEndoscope air/water valve, single-useLuminal device flushing tubing set, single-use

CeroFrict by SML Med-Tech Solutions Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luminal device flushing tubing set, single-use.

Cleared under the same submission

K220884 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SML Med-Tech Solutions Limited

Sources (1)

  • FDA UDI 98c7413a-5704-4a17-bb0e-b2ecf91d304e 34 fields · synced Jun 6, 2026