CareStation Server 80605-003

GUDID 00840241600290

CareStation Server acquires and displays data from the WCD for clinicians to view.

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software
Primary Device ID00840241600290
NIH Device Record Key0671d3b6-965f-4bdd-a573-6431e297072a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareStation Server
Version Model Number80605-003
Catalog Number80605-003
Company DUNS060944361
Company NameKestra Medical Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840241600276 [Previous]
GS100840241600290 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-12

On-Brand Devices [CareStation Server]

00840241600269CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600290CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600276CareStation Server acquires and displays data from the WCD for clinicians to view.
00840241600306CareStation Server acquires and displays data from the WCD for clinicians to view.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.