Topcare Digital Pregnancy Test

GUDID 00036800163218

CB8 Digital Pregnancy Stick Topcare DPS Digital Early US

TOPCO ASSOCIATES, LLC

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• Primary Device ID: 00036800163218
• NIH Device Record Key: 1ab521f3-69c1-4a0b-a14f-178dd6e4a9c8
• Commercial Distribution Discontinuation: 2019-12-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Topcare Digital Pregnancy Test
• Version Model Number: CB8
• 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: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 888-423-0139
• Email: topcare@topco.com
• Phone: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036800163218 [Primary]
GS1	00633472000041 [Unit of Use]
GS1	10036800163215 [Package]; Package: Shipping Case [24 Units]; Discontinued: 2019-12-02; Not 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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-07-06
• Device Publish Date: 2016-06-30

Devices Manufactured by TOPCO ASSOCIATES, LLC

• 10036800396934 - TOPCARE: 2023-11-13 TOPCARE 30 SECOND THERMOMETER
• 00036800060937 - Topcare One Step Pregnancy Test: 2023-07-06 FPPL Topcare DPS +/-
• 00036800115668 - Topcare One Step Pregnancy Test: 2023-07-06 FPPL Topcare SPS +/-
• 00036800163218 - Topcare Digital Pregnancy Test: 2023-07-06CB8 Digital Pregnancy Stick Topcare DPS Digital Early US
• 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