Factplus Pregnancy Test

GUDID 00633472190834

FPPL Fact Plus Visual Pregnancy Stick 2 CT

SPD SWISS PRECISION DIAGNOSTICS GMBH

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

• Primary Device ID: 00633472190834
• NIH Device Record Key: ff86c813-892b-4f60-b772-749cf263dab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Factplus Pregnancy Test
• Version Model Number: FPPL
• 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: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• Email: xx@xx.xx
• Phone: 8009868598
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00633472000133 [Unit of Use]
GS1	00633472190834 [Primary]
GS1	10633472190831 [Package]; Package: Shipping case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-30

Devices Manufactured by SPD SWISS PRECISION DIAGNOSTICS GMBH

• 10761706168537 - CVP Health: 2024-04-12 McLane (CVP Health) DPS +/-
• 10633472602303 - Clearblue: 2024-02-14 Clearblue Preg Dig CB15 1ct - US
• 10633472602310 - Clearblue: 2024-02-14 Clearblue Preg Dig CB15 5ct - US
• 10633472602327 - Clearblue: 2024-02-14 A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests
• 10633472602334 - Clearblue: 2024-02-14 A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests
• 10633472602341 - Clearblue: 2024-02-14 A convenience kit consisting of 1 Digital pregnancy test + 1 visual pregnancy test
• 10633472602365 - Clearblue: 2024-02-14 CB Preg Vis CB16 ED 1ct US
• 10633472602242 - Clearblue: 2023-08-08 CB Menopause Stage Indicator 5ct US