Rempress

GUDID 04560138481004

Nemoto Rempress contrast delivery system for angiography, pedestal type unit.

NEMOTO KYORINDO CO.,LTD.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 04560138481004
• NIH Device Record Key: 0e06183f-281b-4003-bd61-6af1579f3fc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rempress
• Version Model Number: 100
• Company DUNS: 692691710
• Company Name: NEMOTO KYORINDO CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560138481004 [Primary]
GS1	14560138481001 [Package]; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092896

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

Devices Manufactured by NEMOTO KYORINDO CO.,LTD.

• 04560138482605 - PRESS DUO elite: 2018-09-06 Nemoto PRESS DUO elite dual-head angiographic contrast delivery system, separate type unit.
• 04560138481004 - Rempress: 2018-07-06Nemoto Rempress contrast delivery system for angiography, pedestal type unit.
• 04560138481004 - Rempress: 2018-07-06 Nemoto Rempress contrast delivery system for angiography, pedestal type unit.
• 04560138481707 - DUAL SHOT alpha 7: 2018-07-06 Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications.
• 14560138480707 - SONIC SHOT GX: 2018-03-29 Nemoto SONIC SHOT GX contrast delivery system for MRI applications.