DEVICE: BUSULFAN LEVEL 1 (B80001696000070)

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Device Record History
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Device Identifier (DI) Information
BUSULFAN LEVEL 1
BUS 1 P F UK
In Commercial Distribution

UTAK LABORATORIES, INC.
B80001696000070
HIBCC

1
092519016 *Terms of Use
BUSULFAN LEVEL 1
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
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?
66109 Busulfan therapeutic drug monitoring IVD, control
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug busulfan in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LAS Drug Specific Control Materials
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
bcf536b7-e6f3-4194-be64-81a197e16f2a
August 25, 2022
1
August 17, 2022
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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
B80001696000071 4 B80001696000070 In Commercial Distribution Box
B80001696000072 5 B80001696000070 In Commercial Distribution Box
B80001696000073 10 B80001696000070 In Commercial Distribution Box
B80001696000076 25 B80001696000070 In Commercial Distribution Box
B80001696000077 50 B80001696000070 In Commercial Distribution Box
B80001696000078 100 B80001696000070 In Commercial Distribution Box
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888) 882-5522
welovecontrol@utak.com
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