DEVICE: PatientTouch Blood Product Administration (00853209005006)

Device Identifier (DI) Information

PatientTouch Blood Product Administration
3.3.1
In Commercial Distribution
PTA BPA
PATIENTSAFE SOLUTIONS, INC.
00853209005006
GS1

1
134985477 *Terms of Use
The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
44100 Blood bank information system application software
An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.
Active false
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FDA Product Code

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Product Code Product Code Name
MMH Blood Establishment Computer Software And Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK120029 0
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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
Special Storage Condition, Specify: This is standalone software
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3ff9b8bf-f8dd-4b46-b8bc-3644eca41556
July 06, 2018
3
December 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
No CLOSE

Customer Contact

[?]
858-746-3160
support@patientsafesolutions.com
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