Top Care Health

GUDID 00036800458475

CB8 Digital Pregnancy Stick TopCare Digital Pregnancy Test 2ct Blue Cap

TOPCO ASSOCIATES, LLC

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• Primary Device ID: 00036800458475
• NIH Device Record Key: f160d91f-41f1-4bec-9657-063875e018e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Top Care Health
• Version Model Number: Digital Pregnancy Test
• Company DUNS: 072943876
• Company Name: TOPCO ASSOCIATES, LLC
• Device Count: 2
• 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: true

Customer Support Contacts

• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com
• Phone: 1-888-423-0139
• Email: topcare@topco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036800458475 [Primary]
GS1	00633472000041 [Unit of Use]
GS1	10036800458472 [Package]; Package: Shipping case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060128

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2019-06-18
• Device Publish Date: 2019-06-10

Devices Manufactured by TOPCO ASSOCIATES, LLC

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• 00036800115668 - Topcare One Step Pregnancy Test: 2023-07-06 FPPL Topcare SPS +/-
• 00036800163218 - Topcare Digital Pregnancy Test: 2023-07-06 CB8 Digital Pregnancy Stick Topcare DPS Digital Early US
• 00036800339774 - Topcare One Step Pregnancy Test: 2023-07-06 FPPL Topcare TPS +/-
• 00036800384316 - Topcare Early Result Pregnancy Test: 2023-07-06 Topcare DPS Early
• 20036800186808 - TopCare health: 2023-04-04 Sterile Rolled Gauze, 1 roll, 4 IN x 2 1/2 YDS
• 30036800188205 - TopCare health: 2023-04-04 Sterile Rolled Gauze, 1 roll, 2 in x 2 1/2 YDS