DEVICE: VITEK® REVEAL™ SEALER (00860007326912)

Device Identifier (DI) Information

VITEK® REVEAL™ SEALER
900-00003
In Commercial Distribution

BIOMERIEUX , INC.
00860007326912
GS1

1
086785110 *Terms of Use
The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
36674 Package sealing unit
A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.
Active false
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FDA Product Code

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Product Code Product Code Name
SAN Automated antimicrobial susceptibility test system for positive blood culture samples
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K230675 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9d11471a-f920-4dc7-946d-19f5713341c8
October 17, 2024
1
October 09, 2024
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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
No Package DIs found
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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

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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