PCA Lockbox 250 Strap and Pouch

GUDID 27290109151650

EITAN MEDICAL LTD

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• Primary Device ID: 27290109151650
• NIH Device Record Key: f018b30c-02e3-48be-be30-488fe8415bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCA Lockbox 250 Strap and Pouch
• Version Model Number: 15063-000-0004
• 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: false
• 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

• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: 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	17290109151653 [Primary]
GS1	27290109151650 [Package]; Contains: 17290109151653; Package: [24 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: 2024-03-27
• Device Publish Date: 2024-03-19

Devices Manufactured by EITAN MEDICAL LTD

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• 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.
• 27290109154705 - Sapphire Power Supply - US: 2023-09-13
• 27290109154590 - AP411-01: 2023-09-13
• 27290109154804 - AP417-01: 2023-09-13
• 27290109155115 - AP402-01: 2023-09-13