DEVICE: APA™ MAC 3 Blade (clean, non-sterile) (08885009190028)

Device Identifier (DI) Information

APA™ MAC 3 Blade (clean, non-sterile)
700130
In Commercial Distribution
700130
VENNER MEDICAL (SINGAPORE) PTE. LTD.
08885009190028
GS1

1
659177273 *Terms of Use
The laryngoscope with the MAC Blade size 3 attached is used to assist routine endotracheal intubation in a similar manner to a standard Macintosh laryngoscope.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46828 Laryngoscope blade, single-use
The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.
Active 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

[?]
Size Type Text
No Device Sizes
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Device Record Status

dcc64ee7-d0fc-436f-abde-f2ac6bccf96c
October 23, 2018
1
September 22, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
28885009190022 20 18885009190025 In Commercial Distribution Shipper Box
18885009190025 10 08885009190028 In Commercial Distribution 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
No
No
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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