DEVICE: N/A (16974594960235)

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Device Record History
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Device Identifier (DI) Information
N/A
20ml
In Commercial Distribution

HBH BIOTECHNOLOGY LIMITED
16974594960235
GS1

1
404071076 *Terms of Use
Test tube with test tube plug for reagent storage
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
46721 Disposable vacuum tubing
A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KST System, Blood Collection, Vacuum-Assisted, Manual
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
8772cc10-34a7-41e7-90a2-629eaad01682
March 10, 2025
1
March 01, 2025
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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
26974594960232 200 16974594960235 In Commercial Distribution
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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

[?]
No
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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