FreeStyle 70428

GUDID 30093815704288

FreeStyle Unistik 2

ABBOTT DIABETES CARE INC

Glucose monitoring system IVD, home-use

• Primary Device ID: 30093815704288
• NIH Device Record Key: de5ac188-4a67-46b4-8b3c-763fa36b5abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: 70428
• Catalog Number: 70428
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 200
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)522-5226
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815704287 [Primary]
GS1	10093815704284 [Unit of Use]
GS1	30093815704288 [Package]; Contains: 00093815704287; Package: Case [30 Units]; In Commercial Distribution
NDC/NHRIC	99073-0704-28 [Secondary]

FDA Product Code

• FMK: Lancet, blood

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: 2018-08-03
• Device Publish Date: 2018-07-03

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• 30093815704288: FreeStyle Unistik 2