Resp-O2 Tracheostomy Care Kit, Two Compartment Tray w/ Removable Plastic Basin

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Tracheostomy Care Kit, Two Compartment Tray w/ Removable Plastic Basin FDA UDI
Generic Name: Tracheostomy care kit, single-use FDA UDI
Device Name: Nitrile Gloves. STERILE-EO (1) Two-compartment tray (1) Removable plastic basin (1) Pair of nitrile gloves (1) 3-Ply waterproof drape (4) Non-woven gauze, 4" × 4" (1) Tracheostomy dressing (2) Cotton-tipped applicators (1) Twill tape (2) Pipe cleaners (1) Tracheostomy brush FDA UDI
Model / Reference: 35004 FDA UDI
Description: Nitrile Gloves. STERILE-EO (1) Two-compartment tray (1) Removable plastic basin (1) Pair of nitrile gloves (1) 3-Ply waterproof drape (4) Non-woven gauze, 4" × 4" (1) Tracheostomy dressing (2) Cotton-tipped applicators (1) Twill tape (2) Pipe cleaners (1) Tracheostomy brush FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117321366 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, Two Compartment Tray w/ Removable Plastic Basin by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID

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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 57b9c433-35e9-4bf5-a7a9-830f10c60daa 33 fields · synced Jun 1, 2026