Resp-O2 Comfort-Foam Trach Tube Holder 2 PC, Pediatric Maximum Neck Sixe 18"/46…

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Comfort-Foam Trach Tube Holder 2 PC,Pediatric Maximum Neck Sixe 18"/46cm FDA UDI
Generic Name: Tracheostomy tube neck holder, single-use FDA UDI
Device Name: Medium, Maximum Neck Size 18"/46 cm FDA UDI
Model / Reference: 35028 FDA UDI
Description: Medium, Maximum Neck Size 18"/46 cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117319264 FDA UDI
FDA Product Code: CBH FDA UDI
GMDN Term: Tracheostomy tube neck holder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5770 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

FDA UDI

Category: Tracheostomy tube neck holder, single-use

Resp-O2 Comfort-Foam Trach Tube Holder 2 PC, Pediatric Maximum Neck Sixe 18"/46… 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 baa8785f-c32a-417e-9efe-5a7b132c5a70 33 fields · synced May 30, 2026