Trach Tube Holder - Pediatric (9" length)

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Trach Tube Holder - Pediatric (9" length) FDA UDI
Generic Name: Tracheostomy tube neck holder, reusable FDA UDI
Model / Reference: 4621 FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784462134 FDA UDI
FDA Product Code: CBH FDA UDI
GMDN Term: Tracheostomy tube neck holder, reusable 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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tracheostomy tube neck holder, reusable

Trach Tube Holder - Pediatric (9" length) 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 fe327753-6a81-41ba-ab64-8d2f9fc25a86 32 fields · synced May 30, 2026