Pala-Nate

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name: PALA-NATE FDA UDI
Generic Name: Endotracheal tube holder FDA UDI
Device Name: PALATE GUARD Sampler kit, Palate Protection for Neonates, W/ 2 - EXTRA SMALL, 3 - SMALL, 3 - MEDIUM, & 2 - LARGE FDA UDI
Model / Reference: Sampler Kit FDA UDI
Description: PALATE GUARD Sampler kit, Palate Protection for Neonates, W/ 2 - EXTRA SMALL, 3 - SMALL, 3 - MEDIUM, & 2 - LARGE FDA UDI

Identifiers

Catalog Number: 4005000 FDA UDI
Primary DI / UDI-DI: H67140050000 FDA UDI
510(k) Number: K923591 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Endotracheal tube holder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endotracheal tube holder

Pala-Nate by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K923591 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Utah Medical Products, Inc.

Sources (1)

FDA UDI 4943dcb9-05c3-46a4-89e0-fc547d2e1bf1 36 fields · synced Jun 9, 2026