DEVICE: OC-Auto (00855574005100)

Device Identifier (DI) Information

OC-Auto
MV5F00
In Commercial Distribution

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
00855574005100
GS1

1
078413594 *Terms of Use
OC-Auto SENSOR Diana FIT Analyzer
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Faecal occult blood immunoassay analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of faecal occult blood, using an immunological method to detect or measure haemoglobin in a clinical stool (faeces) specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
OOX Automated Occult Blood Analyzer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092330 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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

314718f0-9793-49a8-9d2c-40b51d5385de
July 06, 2018
3
September 23, 2016
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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