AlereTM

GUDID 10815845020116

ALERE SAN DIEGO, INC.

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• Primary Device ID: 10815845020116
• NIH Device Record Key: 3a97d363-c45c-4948-8e00-50199708210b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlereTM
• Version Model Number: 92225
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 40
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815845020119 [Unit of Use]
GS1	10815845020116 [Primary]

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [AlereTM]

• 10815845020130: 92210
• 10815845020123: 92215
• 10815845020116: 92225
• 10815845020109: 92217
• 10815845020093: 92211