DEVICE: ARCHITECT (00380740081911)

Device Identifier (DI) Information

ARCHITECT
1P06-02
In Commercial Distribution
01P0602
ABBOTT LABORATORIES
00380740081911
GS1

100
079226220 *Terms of Use
ARCHITECT Transplant Pretreatment Tubes
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Evacuated blood collection tube IVD, K2EDTA A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MKW CYCLOSPORINE
MLM ENZYME IMMUNOASSAY, TRACROLIMUS
NRP Sirolimus test system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070820 000
K070822 000
K080751 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 15 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

336785b3-3eec-4964-b710-ecf598f613f2
July 06, 2018
3
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

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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: 00380740138875 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(877)422-2688
xx@xx.xx
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