DEVICE: BD PureHub (00382903065974)

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Device Record History
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Device Identifier (DI) Information
BD PureHub
306597
In Commercial Distribution
306597
BECTON, DICKINSON AND COMPANY
00382903065974
GS1

1
001292192 *Terms of Use
CAP DISINFECTION STRIP US
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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?
61141 Luer-formatted disinfection cap
A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QBP Cap, device disinfectant
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K193190 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
e3f9c35b-581e-4547-b2d4-81c8e7093e4f
May 20, 2024
4
May 08, 2020
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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
50382903065979 15 00382903065974 In Commercial Distribution Case
30382903065975 300 00382903065974 In Commercial Distribution Shelfpack
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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