DEVICE: Aggreguide (00856893004065)

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Device Identifier (DI) Information
Aggreguide
A-100
In Commercial Distribution

AGGREDYNE, INC.
00856893004065
GS1

1
078703793 *Terms of Use
Whole Blood Aggregometer
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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?
56698 Platelet aggregation analyser IVD, automated
A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
JOZ System, Automated Platelet Aggregation
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
cf90074f-443b-4f34-90c1-84956284743b
February 01, 2019
1
January 01, 2019
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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
00856893004041 1 00856893004065 In Commercial Distribution Kit
00856893004003 1 00856893004065 In Commercial Distribution Kit
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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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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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