DEVICE: BOON (06938327900014)

Device Identifier (DI) Information

BOON
100103-A
In Commercial Distribution

Shenzhen Baoan Medical Supply Co., Ltd.
06938327900014
GS1

1
529174252 *Terms of Use
1-200 mL Syringe 1-Fill Straw 1-72” Coiled Tubing
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Angiographic syringe A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DXT Injector And Syringe, Angiographic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151960 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
No Device Sizes
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Device Record Status

3a62aed6-85fd-4b97-804f-8634bd359e1a
July 06, 2018
4
November 11, 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
26938327900014 50 06938327900014 In Commercial Distribution Carton
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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