Endure

Basic Information

• Brand Name: Endure
• Primary DI: B531ES1050
• Version / Model: ES1051217
• Catalog Number: ES105
• Company Name: ENDURE INDUSTRIES
• Labeler DUNS: 066087031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-20
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 5124acb8-23aa-4a58-a80e-86f9492d808c

Device Description

Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
BSR	Stylet, Tracheal Tube	Anesthesiology	868.5790	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37469	Artificial airway stylet, single-use	A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B531ES1052	HIBCC	Carton	20	In Commercial Distribution
Package	B531ES1051	HIBCC	Box	20	In Commercial Distribution
Primary	B531ES1050	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			size- 10Fr

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius