APA™ Stylet

Basic Information

• Brand Name: APA™ Stylet
• Primary DI: 08885009190196
• Version / Model: 701009
• Catalog Number: 701009
• Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.
• Labeler DUNS: 659177273
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-25
• Public Version: 2
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 77ef9731-2006-40c2-a2af-444e6268d254

Device Description

A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g. endotracheal tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation).

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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	18885009190193	GS1	Box	10	In Commercial Distribution
Primary	08885009190196	GS1