PALA-NATE 4003000

GUDID H67140030001

PALATE GUARD, Palate Protection for Neonates, 3.0cm X 2.7cm, Large

UTAH MEDICAL PRODUCTS, INC.

Endotracheal tube holder

• Primary Device ID: H67140030001
• NIH Device Record Key: be85b807-dcb0-4f0a-932e-f9280e400c00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALA-NATE
• Version Model Number: Large
• Catalog Number: 4003000
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Width: 3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H67140030000 [Primary]
HIBCC	H67140030001 [Package]; Contains: H67140030000; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923591

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [PALA-NATE]

• H67140050000: PALATE GUARD Sampler kit, Palate Protection for Neonates, W/ 2 - EXTRA SMALL, 3 - SMALL, 3 - MED
• H67140030001: PALATE GUARD, Palate Protection for Neonates, 3.0cm X 2.7cm, Large
• H67140025001: PALATE GUARD, Palate Protection for Neonates, 2.5cm X 2.0cm, Medium
• H67140020001: PALATE GUARD, Palate Protection for Neonates, 2.0cm X 1.8cm, Small
• H67140015001: PALATE GUARD, Palate Protection for Neonates, 1.5cm X 1.3cm, Extra Small