Clearblue Pregnancy Test with Smart Countdown

GUDID 00633472808760

CB12 Digital Pregnancy 5 CT Dual

SPD SWISS PRECISION DIAGNOSTICS GMBH

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Primary Device ID	00633472808760
NIH Device Record Key	f683b497-957c-4396-a788-c7ab84ec4639
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	5
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
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
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	00633472600357 [Package] Package: Shipping Case [12 Units] In Commercial Distribution
GS1	00633472808760 [Primary]

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	3
Public Version Date	2018-07-06
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