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Nar

FDA UDI

Class II (US FDA UDI)

by Well Lead Medical Co., Ltd

Identity

Trade Name
NAR FDA UDI
Generic Name
Tracheostomy tube, reinforced, non-customized, single-use FDA UDI
Device Name
Tracheostomy Tube, Type I, Cuffed, 6.0mm DEHP FREE(Sterile) FDA UDI
Model / Reference
ZZ-0269 FDA UDI
Description
Tracheostomy Tube, Type I, Cuffed, 6.0mm DEHP FREE(Sterile) FDA UDI

Identifiers

Primary DI / UDI-DI
06936881136009 FDA UDI
510(k) Number
K042684 FDA UDI
FDA Product Code
BTO FDA UDI
GMDN Term
Tracheostomy tube, reinforced, non-customized, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostomy tube, reinforced, non-customized, single-use

Nar by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, reinforced, non-customized, single-use.

Cleared under the same submission

K042684 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Well Lead Medical Co., Ltd

Sources (1)

  • FDA UDI ffdb559e-33c1-4d07-b876-34d23a42b0e4 34 fields · synced Jun 8, 2026