APA™ Video Viewer and Charger

Basic Information

• Brand Name: APA™ Video Viewer and Charger
• Primary DI: 08885009190059
• Version / Model: 701000
• Catalog Number: 701000
• 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: 2018-09-22
• Public Version: 1
• Public Version Date: 2018-10-23
• Public Version Status: New
• Public Device Record Key: 2ac5372e-4358-4a38-8702-5a1c4c6d3b82

Device Description

The APA™ Video Laryngoscope is a multi-functional device designed to assist direct and indirect laryngoscopy in routine and difficult airway intubations. It may be used to facilitate endotracheal intubation as part of general anaesthesia or CPR (cardiopulmonary resuscitation) during cardiac arrest. The video laryngoscope is reusable, DEHP-free and latex-free. It is fully detachable into three components: APA™ Video Viewer, APA™ Handle and APA™ MAC or MIL Camera Module. When used as a video laryngoscope, the Video Viewer is attached to the Handle and Camera Module to provide improved visualisation during laryngoscopy and endotracheal intubation.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28885009190053	GS1	Shipper Box	30	In Commercial Distribution
Primary	08885009190059	GS1