STAR 65

GUDID 18904269452886

Multi-Parameter Patient Monitoring System

Skanray Technologies Private Limited

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 18904269452886
• NIH Device Record Key: 1caeba52-bb33-40c4-9991-168a6d80143a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR 65
• Version Model Number: F3-86-390-1000-21
• Company DUNS: 650662203
• Company Name: Skanray Technologies Private Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18904269452886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172147

FDA Product Code

• KRB: Probe, Thermodilution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-01-21

Devices Manufactured by Skanray Technologies Private Limited

• 08904269400460 - Intraskan DC Plus: 2020-08-18 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 Plus: 2020-08-18 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 DC: 2020-08-18 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 DC: 2020-08-18 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 DC: 2020-08-18 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 DC: 2020-08-18 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 HD: 2020-08-18 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 HD: 2020-08-18 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