DEVICE: BD Q-Syte (00382903851003)

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Device Record History
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Device Identifier (DI) Information
BD Q-Syte
385100
In Commercial Distribution
385100
BECTON, DICKINSON AND COMPANY
00382903851003
GS1

1
124987988 *Terms of Use
Q-Syte
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
42743 Negative-pressure intravenous line needleless valve-connector
A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K013621 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

[?]
Size Type Text
No Device Sizes
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Device Record Status
fcecc5e9-b402-4539-b157-91cb5350efc6
May 10, 2023
4
September 16, 2016
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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
50382903851008 200 00382903851003 In Commercial Distribution Case
30382903851004 50 00382903851003 In Commercial Distribution Box
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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)

[?]
Yes
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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