Sapphire M.T. Pump Kit C

GUDID 27290109155306

EITAN MEDICAL LTD

Bedside infusion pump, single-channel

• Primary Device ID: 27290109155306
• NIH Device Record Key: bf1df8a9-88c4-4f65-8dbe-e3d4562a002c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire M.T. Pump Kit C
• Version Model Number: 17000-028-1045
• Company DUNS: 533108028
• Company Name: EITAN MEDICAL LTD
• 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: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 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	07290109155302 [Direct Marking]
GS1	17290109155309 [Primary]
GS1	27290109155306 [Package]; Contains: 17290109155309; Package: cardboard box [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192860

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

Devices Manufactured by EITAN MEDICAL LTD

• 27290109155306 - Sapphire M.T. Pump Kit C: 2024-09-12
• 27290109155306 - Sapphire M.T. Pump Kit C: 2024-09-12
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• 27290109152626 - Avoset Pouch Pro: 2024-07-31
• 27290109152152 - AV0003-01 Avoset Microbore set with 0.2 micron filter and NRFit connector: 2024-07-26 MICROBORE (YELLOW STRIPED) INFUSION SET WITH NON-VENTED SPIKE, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, V
• 27290109151650 - PCA Lockbox 250 Strap and Pouch: 2024-03-27
• 27290109154101 - Travel Case: 2024-03-11
• 17290109155095 - Sapphire MT Infusion Kit 16 – US: 2024-03-04
• 27290109152565 - Avoset Cartridge Set: 2024-01-08 100 ML MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED.