V8800 Critical Care Ventilator 0081508502031

GUDID 00815085020313

Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Spanish Language. Europe Power Setup

ORICARE INC.

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 00815085020313
• NIH Device Record Key: 8ff04d0b-62d9-4a09-877c-4ffc8faa3459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V8800 Critical Care Ventilator
• Version Model Number: V8800
• Catalog Number: 0081508502031
• Company DUNS: 009527042
• Company Name: ORICARE INC.
• 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

Customer Support Contacts

• Phone: 1-215-538-2470
• Email: Suzy@Oricaremed.com
• Phone: 1-215-538-2470
• Email: Suzy@Oricaremed.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815085020313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120931

FDA Product Code

• BTI: Compressor, Air, Portable

Sterilization

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

[00815085020313]

Moist Heat or Steam Sterilization

[00815085020313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-25

On-Brand Devices [V8800 Critical Care Ventilator]

• 00815085020443: Critical Care Ventilator with standard features: Turkish Language. Europe Power Setup
• 00815085020436: Critical Care Ventilator with standard features: Spanish Language. USA Power Setup
• 00815085020429: Critical Care Ventilator with standard features: Spanish Language. Europe Power Setup
• 00815085020412: Critical Care Ventilator with standard features: Russian Language. Europe Power Setup
• 00815085020405: Critical Care Ventilator with standard features: Polish Language. Europe Power Setup
• 00815085020399: Critical Care Ventilator with standard features: German Language. Europe Power Setup
• 00815085020382: Critical Care Ventilator with standard features: French Canada Language. USA Power Setup
• 00815085020375: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. French Language.
• 00815085020368: Critical Care Ventilator with standard features: English Language. Europe Power Setup
• 00815085020351: Critical Care Ventilator with standard features: English Language. USA Power Setup
• 00815085020344: Critical Care Ventilator with standard features: Chinese Language. China Power Setup
• 00815085020337: Critical Care Ventilator with standard features: Turkish Language. Europe Power Setup
• 00815085020320: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Spanish Language.
• 00815085020313: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Spanish Language.
• 00815085020306: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Russian Language.
• 00815085020290: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Polish Language.
• 00815085020283: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. German Language.
• 00815085020276: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. French Canada Lan
• 00815085020269: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. French Language.
• 00815085020252: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. English Language.
• 00815085020245: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. English Language.
• 00815085020238: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Chinese Language.