DEVICE: UNIBLOCKER (04544050080965)

Device Identifier (DI) Information

UNIBLOCKER
5.0FR
In Commercial Distribution
1203104
FUJI SYSTEMS CORPORATION
04544050080965
GS1

1
715919973 *Terms of Use
UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
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
Bronchial balloon catheter A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K894337 000
No CLOSE

Sterilization

Yes
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

8a525baa-f35b-4aac-b6ef-a2bba69f8cba
July 06, 2018
3
September 24, 2015
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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

[?]
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
No
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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