APA™ Video Viewer and Charger - The APA™ Video Laryngoscope is a multi-functional - VENNER MEDICAL (SINGAPORE) PTE. LTD.

Duns Number:659177273

Device Description: The APA™ Video Laryngoscope is a multi-functional device designed to assist direct and ind 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.

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More Product Details

Catalog Number

701000

Brand Name

APA™ Video Viewer and Charger

Version/Model Number

701000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

2ac5372e-4358-4a38-8702-5a1c4c6d3b82

Public Version Date

October 23, 2018

Public Version Number

1

DI Record Publish Date

September 22, 2018

Additional Identifiers

Package DI Number

28885009190053

Quantity per Package

30

Contains DI Package

08885009190059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"VENNER MEDICAL (SINGAPORE) PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 7