CVS Health Digital Pregnancy Test

GUDID 00050428255445

CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER)

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00050428255445
• NIH Device Record Key: eaad4bc6-f133-4144-b576-d2370d60aa08
• Commercial Distribution Discontinuation: 2019-09-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CVS Health Digital Pregnancy Test
• Version Model Number: CB8
• Company DUNS: 062312574
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• 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: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428255445 [Primary]
GS1	00633472000041 [Unit of Use]
GS1	10050428255442 [Package]; Package: Shipping Case [24 Units]; Discontinued: 2019-09-27; 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: 4
• Public Version Date: 2019-09-30
• Device Publish Date: 2016-06-30

On-Brand Devices [CVS Health Digital Pregnancy Test]

• 00050428436288: CB8 PL Digital Pregnancy Stick CVS DPS Yes/No Digital
• 00050428255445: CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER)