Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile FDA UDI
Generic Name: Tracheostomy care kit, single-use FDA UDI
Device Name: (1) One-compartment mini-tray (2) Non-woven gauze, 4" × 4" (2) Tracheostomy dressing (2) Cotton-tipped applicators (2) Pipe cleaners (1) Hydrogen peroxide 1 oz. pack FDA UDI
Model / Reference: 35009 FDA UDI
Description: (1) One-compartment mini-tray (2) Non-woven gauze, 4" × 4" (2) Tracheostomy dressing (2) Cotton-tipped applicators (2) Pipe cleaners (1) Hydrogen peroxide 1 oz. pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117321410 FDA UDI
FDA Product Code: LRQ FDA UDI
GMDN Term: Tracheostomy care kit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostomy care kit, single-use

Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Dynarex Corp.

Sources (1)

FDA UDI 5cf8da48-a623-4a68-a59c-998b59b15390 33 fields · synced May 29, 2026