DEVICE: Dimension Vista® Flex® reagent cartridge PROC (00842768015403)

Device Identifier (DI) Information

Dimension Vista® Flex® reagent cartridge PROC
10445130
Not in Commercial Distribution
K4110
Siemens Healthcare Diagnostics Inc.
00842768015403
GS1
April 12, 2024
2
005088112 *Terms of Use
Procainamide Flex® reagent cartridge, 80 tests
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
61896 Procainamide therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug procainamide in a clinical specimen, using a nephelometry/turbidimetry method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LAR ENZYME IMMUNOASSAY, PROCAINAMIDE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061655 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

26817c21-95ba-4c40-902d-8ea818b93c34
April 15, 2024
6
September 24, 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
No Package DIs found
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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: 00630414005010 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)441-9250
CONTACT@SIEMENS-HEALTHINEERS.COM
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