DEVICE: Airtraq (00693602615217)

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Device Record History
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Device Identifier (DI) Information
Airtraq
A-521
In Commercial Distribution

Prodol Meditec Limited
00693602615217
GS1

1
421368931 *Terms of Use
Airtraq Avant Disposable Blade Small - Size 2 + Eyecup
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
64884 Channelled video intubation laryngoscope
A hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube channel guide without use of a stylet for positioning. It typically consists of a body with an ET tube channel, an anatomically-shaped blade, and integrated electronic illumination and a video camera at the distal end; images are transmitted to an off-the-shelf device (e.g., tablet, smartphone, computer). This is a single-use 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

[?]
Size Type Text
No Device Sizes
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Device Record Status
45f16ee3-98e5-4674-beca-8b1252c03cb6
October 24, 2024
1
October 16, 2024
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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
60693602615219 10 00693602615217 In Commercial Distribution
50693602615212 50 00693602615217 In Commercial Distribution
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Secondary DI

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

[?]
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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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