Resp-O2 Comfort-Foam Trach Tube Holder 1PC, Neonatal & Infant, Neck 7"-9"/18-23…

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Comfort-Foam Trach Tube Holder 1PC,Neonatal & Infant,Neck 7"-9"/18-23cm FDA UDI
Generic Name: Tracheostomy tube neck holder, single-use FDA UDI
Device Name: Small, Neonatal and Infant, Neck 7-9"/18-23cm FDA UDI
Model / Reference: 35020 FDA UDI
Description: Small, Neonatal and Infant, Neck 7-9"/18-23cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117312296 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 1PC, Neonatal & Infant, Neck 7"-9"/18-23… 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 3ad2ba84-99c0-4604-b2d1-8f3c2ebad2ac 33 fields · synced May 29, 2026