STAR 65

GUDID 18904269452886

Multi-Parameter Patient Monitoring System

Skanray Technologies Private Limited

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID18904269452886
NIH Device Record Key1caeba52-bb33-40c4-9991-168a6d80143a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAR 65
Version Model NumberF3-86-390-1000-21
Company DUNS650662203
Company NameSkanray Technologies Private Limited
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118904269452886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRBProbe, Thermodilution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-01-21

Devices Manufactured by Skanray Technologies Private Limited

08904269400460 - Intraskan DC Plus2020-08-18 Intraskan DC Plus with 33" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radi
08904269400477 - Intraskan DC Plus2020-08-18 Intraskan DC Plus Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography fo
08904269400521 - Rayos DC2020-08-18 Rayos DC with 15" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography f
08904269400538 - Rayos DC2020-08-18 Rayos DC with 24" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography f
08904269400545 - Rayos DC2020-08-18 Rayos DC with 33" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography f
08904269400552 - Rayos DC2020-08-18 Rayos DC Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnos
08904269400569 - Imagescan HD2020-08-18 Imagescan HD with 15" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiograp
08904269400576 - Imagescan HD2020-08-18 Imagescan HD with 24" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiograp
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.