CVS Health At Home 50428654200

GUDID 00860008357847

Dry blood spot card collection kit utilizing Whatman 903 collection card and Hologic Aptima Urine transport tube.

Blackfly Investments, LLC

Dried blood spot collection kit IVD

• Primary Device ID: 00860008357847
• NIH Device Record Key: fb2588e9-62f3-4ec1-b6b1-9bff04bf4bc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVS Health At Home
• Version Model Number: STI collection kit
• Catalog Number: 50428654200
• Company DUNS: 069497839
• Company Name: Blackfly Investments, LLC
• 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: true
• Device Combination Product: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008357847 [Primary]

FDA Product Code

• LIO: Device, Specimen Collection

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: 2022-08-01
• Device Publish Date: 2022-07-23

On-Brand Devices [CVS Health At Home]

• 00860008357830: Dry blood spot collection kit using Whatman 903 card
• 00860008357823: Dry blood spot card collection kit utilizing Whatman 903 collection card.
• 00860008357816: Dry blood spot collection kit using Whatman 903 card
• 00860008357809: Dry blood spot card collection kit utilizing Whatman 903 collection card.
• 00860008357847: Dry blood spot card collection kit utilizing Whatman 903 collection card and Hologic Aptima Urin