Marpac Inc

FDA UDI

Class I (US FDA UDI)

by Marpac, Inc.

Identity

Trade Name: Marpac Inc FDA UDI
Generic Name: Endotracheal tube holder FDA UDI
Device Name: Endotracheal tube holder, adjustable, adult, NO adhesive on patient face FDA UDI
Model / Reference: 320 FDA UDI
Description: Endotracheal tube holder, adjustable, adult, NO adhesive on patient face FDA UDI

Identifiers

Primary DI / UDI-DI: 00653658003208 FDA UDI
FDA Product Code: CBH FDA UDI
GMDN Term: Endotracheal tube holder 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: Endotracheal tube holder

Marpac Inc by Marpac, Inc. — 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: Marpac, Inc.

Sources (1)

FDA UDI eeaa4e42-2927-4635-9b92-a9595d6c40ea 34 fields · synced May 30, 2026