DEVICE: TEXAS (04055207033760)

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Device Identifier (DI) Information

TEXAS
825200842
82520.0842
Richard Wolf GmbH
04055207033760
GS1
1
BRONCHOSCOPE-TUBE ID 11MM OD 13.2mm, TL 351mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, with distal viewing window, graduated, reusable
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bronchoscopy tube A hollow cylinder composed of plastic, rubber, or other material that is inserted orally into the trachea to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. It has a cuff at the distal end, similar to that of a cuffed endotracheal (ET) tube and may be packaged with a connector that attaches to a breathing circuit. It has a large enough bore to accommodate a flexible bronchoscope; this can enhance the safety of the procedure. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KTI BRONCHOSCOPE ACCESSORY
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Hydrogen Peroxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 11 Millimeter
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Device Status

In Commercial Distribution
September 26, 2016

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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
No Package DIs found
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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
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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