Clearblue Easy Ovulation Kit N/A

GUDID 00633472155642

A convenience kit consisting of 7 Clearblue Easy Ovulation Test device and 1 Clearblue Pregnancy Test with Smart Countdown device

SPD SWISS PRECISION DIAGNOSTICS GMBH

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

• Primary Device ID: 00633472155642
• NIH Device Record Key: 59a6d66c-3c89-4e3a-8806-c739e9809e87
• Commercial Distribution Discontinuation: 2016-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Clearblue Easy Ovulation Kit
• Version Model Number: HOT / CB12
• 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: true
• 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: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• Email: xx@xx.xx
• Phone: 800-321-3279
• 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	00633472155642 [Primary]
GS1	00633472600548 [Package]; Package: Shipping case [6 Units]; Discontinued: 2016-10-31; 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: 2019-02-21
• Device Publish Date: 2016-06-30

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