EXACTAMIX 5030100016

GUDID 18033718000955

1000 mL Empty EVA bag

HAEMOTRONIC SPA

Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle Intravenous administration bag/bottle

• Primary Device ID: 18033718000955
• NIH Device Record Key: 7425962c-4d98-4b6f-aa43-cfe0494225a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTAMIX
• Version Model Number: E3010OD
• Catalog Number: 5030100016
• Company DUNS: 430857771
• Company Name: HAEMOTRONIC SPA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033718000958 [Primary]
GS1	18033718000955 [Package]; Contains: 08033718000958; Package: [50 Units]; In Commercial Distribution
GS1	28033718000952 [Package]; Contains: 08033718000958; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• KPE: Container, I.V.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [EXACTAMIX ]

• 18033718000979: 2000mL Exactamix Empty EVA bag
• 18033718000917: 500 mL Exacatmix Empty EVA bag
• 18033718000900: 250 mL Exactamix Empty EVA bag
• 18033718000955: 1000 mL Empty EVA bag
• 18033718001006: 5000 mL Exactamix Empty EVA bag
• 18033718000993: 4000 mL Exactamix Empty EVA bag
• 18033718000986: 3000 mL Exactamix Empty EVA bag
• 28033718001102: 125 mL ExactaMix EVA
• 08033718000965: 1000 mL ExactaMix EVA Multiple (5 bags)
• 08033718000941: 500 mL ExactaMix EVA Multiple (5 bags)
• 08033718000934: 250 mL ExactaMix EVA multiple (5 bags)