DEVICE: TransPorter® (38053326008857)

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Device Record History
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Device Identifier (DI) Information
TransPorter®
4142
In Commercial Distribution
4142
COPAN ITALIA SPA
38053326008857
GS1

50
428981112 *Terms of Use
SINGLE LIQUID AMIES(ORANGE) ALUMINIUM APPLICATOR RAYON TIPPED
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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?
65196 General specimen collection kit
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JSM Culture Media, Non-Propagating Transport
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K946288 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
9630a98d-68cb-4e3f-acba-e02aade5d0c9
December 15, 2022
1
December 07, 2022
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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
58053326008851 10 38053326008857 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 18053326008853 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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