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

• 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

• 10633472602532 - Clearblue: 2025-08-07 CLEARBLUE OVUL DIG 40CT US
• 10041163504445 - Equaline: 2025-04-08 SuperValu DPS DIG Wide-Tip Blue
• 10633472602488 - Clearblue: 2025-02-13 A convenience kit containing of 6 Early Tests and 1 Early Digital Test
• 10633472602372 - Clearblue: 2024-12-19 A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles
• 10633472602389 - Clearblue: 2024-11-07 CB Birth Control Refill 15ct US
• 00633472602399 - Clearblue: 2024-08-12 Clearblue Ovul Dig 30ct. US
• 00633472602405 - Clearblue: 2024-08-12 A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests
• 00633472602412 - Clearblue: 2024-08-12 A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnancy tests