ChemWell® FUSION 4800

GUDID 00850229007225

AWARENESS TECHNOLOGY, INCORPORATED

Multiple clinical chemistry analyser IVD, laboratory, automated

• Primary Device ID: 00850229007225
• NIH Device Record Key: ad0d1fb8-05c7-44ff-8983-1f2c7a260d70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChemWell® FUSION
• Version Model Number: 4800
• Catalog Number: 4800
• Company DUNS: 071065130
• Company Name: AWARENESS TECHNOLOGY, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com
• Phone: 1-772-283-6540
• Email: sandrus@awaretech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850229007225 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

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: 2022-03-11
• Device Publish Date: 2022-03-03

Devices Manufactured by AWARENESS TECHNOLOGY, INCORPORATED

• 00850229007010 - StatFax: 2023-06-13
• 00850229007027 - StatFax: 2023-06-13
• 00850229007034 - StatFax: 2023-06-13
• 00850229007041 - StatFax: 2023-06-13
• 00850229007072 - StatFax: 2023-06-13 Digital Dry Bath
• 00850229007089 - StatFax: 2023-06-13 Digital Dry Bath
• 00850229007102 - StatFax: 2023-06-13
• 00850229007126 - LumiStat: 2023-06-13