Question 1

What types of medical devices does Venner Medical primarily manufacture?

Accepted Answer

Venner Medical specializes in airway management devices, producing both single-use and reusable products. Their portfolio includes laryngoscope blades (both single-use and reusable), reinforced and non-reinforced endotracheal tubes, tracheostomy tubes, and accessories like cuff inflators, stylets, and camera modules for video laryngoscopy. Some devices are also designed for MRI compatibility, such as certain endotracheal and tracheostomy tubes. These products are used in critical procedures like intubation and tracheostomy.

Question 2

Where is Venner Medical based, and where are its devices manufactured?

Accepted Answer

Venner Medical (Singapore) Pte. Ltd. is based in the US, though the company’s headquarters is located in Singapore. The specific manufacturing locations are not provided, but their devices are designed and developed to meet regulatory standards for use in clinical settings worldwide.

Question 3

Which regulatory registries list Venner Medical’s devices?

Accepted Answer

Venner Medical’s devices are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track submissions for devices classified under FDA regulations, ensuring transparency in their regulatory status. The 510(k) process is used for Class II devices, while Class I devices may also appear in these listings depending on their design controls and compliance requirements.

Question 4

How are Venner Medical’s devices classified under FDA regulations?

Accepted Answer

Venner Medical’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and often require general controls, while Class II devices involve a higher risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for submission, such as the 510(k) process for Class II devices, though Class I devices may still require documentation depending on their design.

Device	Model / Reference	Registries	Class	Status
APA™ Video Viewer and Charger	701000	FDA UDI	Class I	Active
APA™ MIL Camera Module(S)	702910	FDA UDI	Class I	Active
APA IP Shield™ DL	701010	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ ETT MRI	901170	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ ETT	901070	FDA UDI	Class II	Active
Venner™ Tracheal Seal Monitor Extension Tube	903001	FDA UDI	Class I	Unknown
APA IP Shield™ VL	701011	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ ETT	901090	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ TT	902070	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ TT MRI	902180	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ TT	902090	FDA UDI	Class II	Active
APA™ Stylet	701009	FDA UDI	Class I	Active
Venner™ Tracheal Seal Monitor	903200	FDA UDI	Class II	Active
APA™ U-DAB (clean, non-sterile)	700180	FDA UDI	Class I	Active
APA™ Handle	701006	FDA UDI	Class I	Active
APA™ DAB (clean, non-sterile)	700170	FDA UDI	Class I	Active
APA™ MIL Camera Module(L)	702930	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ ETT MRI	901160	FDA UDI	Class II	Active
APA™ O2 MAC 3 Blade	700330	FDA UDI	Class I	Active
Apa™ O2 Dab	700370	FDA UDI	Class I	Active
APA™ MAC 3 Blade (clean, non-sterile)	700130	FDA UDI	Class I	Active
APA™ MAC Camera Module	700930	FDA UDI	Class I	Active
Apa™ O2 U-Dab	700380	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ ETT MRI	901180	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ ETT	901080	FDA UDI	Class II	Active
APA™ O2 MAC 4 Blade	700340	FDA UDI	Class I	Active
Venner PneuX TSM™ Extension Tube(non-sterile)	903010	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ ETT	901060	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ TT MRI	902190	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ TT MRI	902170	FDA UDI	Class II	Active
APA™ MAC 4 Blade (clean, non-sterile)	700140	FDA UDI	Class I	Active
APA™ MIL 1 Blade (clean, non-sterile)	702110	FDA UDI	Class I	Active
APA™ MIL 2 Blade (clean, non-sterile)	702120	FDA UDI	Class I	Active
Venner™ PneuX P.Y.™ TT	902080	FDA UDI	Class II	Active
Venner™ PneuX P.Y.™ ETT MRI	901190	FDA UDI	Class II	Active
Venner Pneux P.y. (tm) Tracheostomy Tube	K100950	FDA 510(k)	Class II	Active
APA Oxy Blade	K191602	FDA 510(k)	Class I	Active
Venner Tracheal Seal Monitor	K110631	FDA 510(k)	Class II	Active
Venner Pneux P.y. (tm) Tracheostomy Tube And Endo Tracheal Tube	K093135	FDA 510(k)	Class II	Active
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm	K192120	FDA 510(k)	Class II	Active
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm	K192511	FDA 510(k)	Class II	Active

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