Clearblue N/A

GUDID 10633472602365

CB Preg Vis CB16 ED 1ct US

SPD SWISS PRECISION DIAGNOSTICS GMBH

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

• Primary Device ID: 10633472602365
• NIH Device Record Key: adc01c0a-4be2-4dc5-b784-6699439a756c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearblue
• Version Model Number: Early Detection Pregnancy Test
• Catalog Number: N/A
• Company DUNS: 483609579
• Company Name: SPD SWISS PRECISION DIAGNOSTICS GMBH
• 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: 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: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com
• Phone: 1-800-321-3279
• Email: xx@xx.com

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	00633472602368 [Primary]
GS1	10633472602365 [Package]; Contains: 00633472602368; Package: Shipping Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213379

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-14
• Device Publish Date: 2024-02-06

On-Brand Devices [Clearblue]

• 10633472601542: A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid Detecti
• 10633472601344: COTS Clearblue 25ct Ovulation + CB12 3ct Digital Pregnancy Bundle
• 00633472601323: CB6 Visual Pregnancy 2ct US
• 10633472601207: CBCOT Ovulation Advanced 25ct
• 10633472601153: A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 Cle
• 10633472601146: CB12 Pregnancy Digital- 1CT
• 10633472601023: A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid De
• 10633472601894: CBCOT Ovulation Advanced 40ct
• 10633472601849: CB11a Visual Pregnancy 1 Ct
• 10633472600767: CBDOT Clearblue Ovulation Digital 10ct Dual
• 00633472600630: CBHOT Visual Ovulation Stick 5 Ct
• 00633472600708: ADOT Clearblue Advanced Ovulation 20ct March of Dimes Dual US
• 00633472600715: ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US
• 10633472600224: Clearblue Fertility Monitor with touch screen 1ct US
• 00633472022258: Clearblue Fertility Monitor with touch screen fertility test sticks 30 ct
• 10633472601719: CB11a Visual Pregnancy 2 Ct
• 10633472276894: Clearblue Digital Ovulation Test 20ct dual
• 10633472602051: A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid
• 10633472602099: Clearblue Advanced Period Tracker 18ct
• 10633472602198: A convenience kit consisting of 25 Clearblue Digital Ovulation Tests and 2 Clearblue Rapid Dete
• 10633472602181: A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearblue Ra
• 10633472602259: Clearblue Preg Dig CB15 3ct US
• 10633472602235: CB Triple Conf Preg Test 3ct US
• 10633472602297: CB Preg Vis CB16 ED 5ct US
• 10633472602280: CB Preg Vis CB16 ED 3ct US
• 10633472602273: CB Preg Vis CB16 ED 2ct US
• 10633472602266: Clearblue Preg Dig CB15 2ct - US
• 10633472602242: CB Menopause Stage Indicator 5ct US
• 10633472602365: CB Preg Vis CB16 ED 1ct US
• 10633472602341: A convenience kit consisting of 1 Digital pregnancy test + 1 visual pregnancy test
• 10633472602334: A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests
• 10633472602327: A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests
• 10633472602310: Clearblue Preg Dig CB15 5ct - US
• 10633472602303: Clearblue Preg Dig CB15 1ct - US
• 00633472602412: A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnanc
• 00633472602405: A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnanc
• 00633472602399: Clearblue Ovul Dig 30ct. US
• 10633472602389: CB Birth Control Refill 15ct US
• 10633472602372: A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 mont