Clearblue Pregnancy Test with Smart Countdown

GUDID 00633472002908

CB12 Pregnancy Digital 2 CT

SPD SWISS PRECISION DIAGNOSTICS GMBH

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

• Primary Device ID: 00633472002908
• NIH Device Record Key: c07ab6fe-41f9-4ebf-8b35-c088568e6e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearblue Pregnancy Test with Smart Countdown
• Version Model Number: CB12
• Company DUNS: 483609579
• Company Name: SPD SWISS PRECISION DIAGNOSTICS GMBH
• 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: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• Email: xx@xx.xx
• Phone: 8003213279
• 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
• 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	00633472000072 [Unit of Use]
GS1	00633472002908 [Primary]
GS1	00633472032905 [Package]; Package: Shipping Case [24 Units]; In Commercial Distribution
GS1	00633472601378 [Package]; Package: Shipping Case [4 Units]; Discontinued: 2016-11-01; Not in Commercial Distribution
GS1	00633472601385 [Package]; Package: Shipping Case [12 Units]; Discontinued: 2017-04-26; Not in Commercial Distribution
GS1	00633472601644 [Package]; Package: Shipping Case [12 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-02
• Device Publish Date: 2016-06-30

On-Brand Devices [Clearblue Pregnancy Test with Smart Countdown]

• 00633472808760: CB12 Digital Pregnancy 5 CT Dual
• 00633472002953: CB12 Digital Pregnancy 3 CT Dual
• 00633472002908: CB12 Pregnancy Digital 2 CT