DEVICE: SpectraVue (06938327901608)

Device Identifier (DI) Information

SpectraVue
400101-1
In Commercial Distribution
99-HT-L1500C
Shenzhen Boon Medical Supply Co., Ltd.
06938327901608
GS1
December 31, 9999
1
529174252 *Terms of Use
60" (1500mm) 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© 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?
44685 Radiographic procedure tubing
A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

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

3b38e980-f486-4f34-b2e8-b4505d273c93
June 24, 2025
2
October 11, 2022
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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
16938327901605 50 06938327901608 9999-12-31 In Commercial Distribution box
26938327901602 2 16938327901605 9999-12-31 In Commercial Distribution carton
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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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
(800) 859-6162
Info@spectrumxray.com
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