DEVICE: Talis EMR with +ACG (00860012608805)

Device Identifier (DI) Information

Talis EMR with +ACG
Talis EMR with +ACG
In Commercial Distribution
Talis EMR with +ACG
Talis Clinical, LLC
00860012608805
GS1

1
078779965 *Terms of Use
Talis EMR with +ACG is software intended to support patient care and billing documentation requirements and process control criteria defined by medical facility
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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?
61087 Clinical management support software
An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233133 000
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

478df09f-5e19-48d4-a8db-ebf428a167f2
October 21, 2024
2
September 24, 2024
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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
Yes
No CLOSE

Customer Contact

[?]
844-522-2846
DL-Talisclinical-SupportRelay@getinge.com
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