PALA-NATE

Basic Information

• Brand Name: PALA-NATE
• Primary DI: H67140020000
• Version / Model: Small
• Catalog Number: 4002000
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2019-12-18
• Public Version Status: Update
• Public Device Record Key: 1c7f61b0-5712-48fb-be99-76f4a717bf9f

Device Description

PALATE GUARD, Palate Protection for Neonates, 2.0cm X 1.8cm, Small

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35815	Endotracheal tube holder	A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H67140020001	HIBCC	Box	10	In Commercial Distribution
Primary	H67140020000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K923591	000

Device Sizes

Type	Value	Unit	Text
Length	1.8	Centimeter
Width	2	Centimeter