DEVICE: BD Vacutainer® Luer-Lok™ Access Device (00382903649020)

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Device Record History
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Device Identifier (DI) Information
BD Vacutainer® Luer-Lok™ Access Device
36490200
In Commercial Distribution
36490200
BECTON, DICKINSON AND COMPANY
00382903649020
GS1

1
001292192 *Terms of Use
BD LUER-LOK ACCESS DEVICE
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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?
60579 Luer-ended blood collection tube spike
A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
JKA Tubes, vials, systems, serum separators, blood collection
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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

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Storage and Handling
Special Storage Condition, Specify: Room Temperature
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
6b859569-1828-47af-9563-8a6490e20a86
October 07, 2024
2
April 09, 2024
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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
60382903649022 198 00382903649020 In Commercial Distribution Case
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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