DEVICE: Donor Doc (00812747010200)

Device Identifier (DI) Information

Donor Doc
3.x.x
In Commercial Distribution

HAEMONETICS CORPORATION
00812747010200
GS1

1
057827420 *Terms of Use
Donor Doc version 3.x.x
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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?
60065 Configurable electronic form web-based application software
An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip].
Active false
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FDA Product Code

[?]
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 [?]
BK140183 0
No 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

02d3151a-12ce-422a-beae-b2ca2d292ef6
August 27, 2018
1
July 27, 2018
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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: 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
No
No
No CLOSE

Customer Contact

[?]
+1(800)-537-2802
pirdesk@Haemonetics.com
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