Sapphire Power Supply - US

GUDID 27290109154705

EITAN MEDICAL LTD

Basic power supply, reusable

• Primary Device ID: 27290109154705
• NIH Device Record Key: 58df24ba-0cd9-4bed-81b3-badbe36c27d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire Power Supply - US
• Version Model Number: 15072-000-0007
• Company DUNS: 533108028
• Company Name: EITAN MEDICAL 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109154701 [Direct Marking]
GS1	17290109154708 [Primary]
GS1	27290109154705 [Package]; Contains: 17290109154708; Package: [10 Units]; In Commercial Distribution
GS1	27290109154712 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192860

FDA Product Code

• MRZ: Accessories, 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: 2023-09-13
• Device Publish Date: 2023-09-05

Devices Manufactured by EITAN MEDICAL LTD

• 07290109155296 - Sapphire PCA Lockbox 500mL Label: 2024-12-09
• 27290109155283 - AP426-01: 2024-12-09 NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK
• 17290109152728 - Eitan Medical: 2024-11-27 100 mL MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED
• 27290109155306 - Sapphire M.T. Pump Kit C: 2024-09-12
• 27290109152619 - 50/100 Avoset Pouch: 2024-07-31
• 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