First Response Early Result Pregnancy Test

GUDID 00022600020141

CHURCH & DWIGHT CO., INC.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00022600020141
• NIH Device Record Key: 95716bf9-91a0-45b5-855a-7aa352c504e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Response Early Result Pregnancy Test
• Version Model Number: 00022600020141
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00022600020141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123436

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: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2019-02-25

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• 00022600902423 - Trojan Supra™ Premium Condoms Non-Latex Bareskin™: 2023-09-27 For Contraception Plus STI Protection
• 00022600019466 - Trojan™ Premium Latex Condoms Pleasure Pack: 2023-09-21 Pack contains Trojan Double Ecstasy Trojan Charged Trojan Ultra Ribbed Trojan ENZ
• 00022600020165 - Trojan™ Premium Latex Condoms Pleasure Pack: 2023-09-21 Pack contains: Trojan Double Ecstasy Trojan Ultra Thin Trojan Fire & Ice Trojan Ultra Ribbed Trojan ENZ
• 80022600901255 - First Response™ Pregnancy Early Result: 2023-07-06 Pregnancy Kit
• 00022600019558 - First Response™ Pregnancy Pro Digital Pregnancy Test & App Access: 2023-07-06