DEVICE: i-STAT (00054749001248)

Device Identifier (DI) Information

i-STAT
06P17-16
In Commercial Distribution
06P17-16
ABBOTT POINT OF CARE INC.
00054749001248
GS1

10
079226216 *Terms of Use
i-STAT ACT, CONTROL LEVEL 2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Activated clotting time (ACT) IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
GGN PLASMA, COAGULATION CONTROL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

a39b489b-71b9-4810-99fa-765d39570fa3
March 29, 2018
2
September 09, 2016
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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: 10054749001245 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)366-8020
techsvc@apoc.abbott.com
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