DEVICE: APA™ MIL Camera Module(L) (08885009190233)

Device Identifier (DI) Information

APA™ MIL Camera Module(L)
702930
In Commercial Distribution
702930
VENNER MEDICAL (SINGAPORE) PTE. LTD.
08885009190233
GS1

1
659177273 *Terms of Use
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(Small and Large size). When used as a standard laryngoscope, the appropriate Camera Module is attached to the Handle to obtain a view of the laryngeal inlet during endotracheal intubation. 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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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
CCW Laryngoscope, Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

afcaae1d-a050-4e20-95e7-faf7a0704284
October 23, 2018
1
September 22, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
28885009190237 30 08885009190233 In Commercial Distribution Shipper Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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