DEVICE: UF ll CALIBRATOR (04987562408535)

Device Identifier (DI) Information

UF ll CALIBRATOR
06404310
In Commercial Distribution

SYSMEX CORPORATION
04987562408535
GS1

2
690664461 *Terms of Use
UF ll CALIBRATOR
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Urine sediment IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.
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FDA Product Code

[?]
Product Code Product Code Name
JIW CALIBRATOR, SURROGATE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070910 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 10 Degrees Celsius
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Clinically Relevant Size

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

130ea8b5-88a5-469f-b916-746a924858fd
September 18, 2018
5
October 06, 2017
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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: 84987562408531 CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(888)879-7639
crc@sysmex.com
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