DEVICE: Chang C 14ML Frozen Supplement (00857515006115)

Device Identifier (DI) Information

Chang C 14ML Frozen Supplement
C106-14ML
In Commercial Distribution
C106
FUJIFILM IRVINE SCIENTIFIC, INC.
00857515006115
GS1

1
057475246 *Terms of Use
Chang C 14ML Frozen Supplement
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
60095 Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
A substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KIT Media And Components, Synthetic Cell And Tissue Culture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: less than -10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 14 Milliliter
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Device Record Status

d3d61724-a8f0-4fd2-bafd-d38531abbbc1
April 29, 2021
1
April 21, 2021
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
8004375706
tmrequest@irvinesci.com
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