DEVICE: Portex (00351688069262)

Device Identifier (DI) Information

Portex
4910NM-18
In Commercial Distribution

SMITHS MEDICAL ASD, INC.
00351688069262
GS1

1
137835299 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General-purpose catheter connector, non-sterile A small, non-sterile device intended to create a mechanical union between a catheter and an external device (e.g., external drainage system) typically via a Luer connection; it is not dedicated to a specific type of catheter. It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
CAZ Anesthesia conduction kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092657 000
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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

11725e7c-eed3-470a-8b1c-ea23e7887998
August 09, 2018
4
January 12, 2017
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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
10351688069269 10 00351688069262 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)

[?]
No
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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