Trach O-Life™

FDA UDI

Class I (US FDA UDI)

by Cutting Edge Hc Brands Llc

Identity

Trade Name: Trach O-Life™ FDA UDI
Generic Name: Tracheostomy care kit, single-use FDA UDI
Device Name: Trach O-Life Tracheostomy Care Kit, One Tray Compartment FDA UDI
Model / Reference: RTG-02500 FDA UDI
Description: Trach O-Life Tracheostomy Care Kit, One Tray Compartment FDA UDI

Identifiers

Catalog Number: RTG-02500 FDA UDI
Primary DI / UDI-DI: 00850108006448 FDA UDI
FDA Product Code: KDD FDA UDI
GMDN Term: Tracheostomy care kit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tracheostomy care kit, single-use

Trach O-Life™ by Cutting Edge Hc Brands Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tracheostomy care kit, single-use.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Cutting Edge Hc Brands Llc

Sources (1)

FDA UDI e5639ee6-ed38-49ac-bdaa-264dd6ed6dc7 36 fields · synced May 30, 2026