AccessGUDID - DEVICE: Clearblue (00633472600401)

GUDID

Device Identifier (DI) Information

Brand Name: Clearblue
Version or Model: Advanced Digital Ovulation Test
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SPD SWISS PRECISION DIAGNOSTICS GMBH

Primary DI Number: 00633472600401
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 483609579 *Terms of Use

Device Description: ADOT Clearblue Advanced Ovulation 20ct March of Dimes Dual US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60862	Natural conception assistance kit	A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGE	Test, Luteinizing Hormone (Lh), Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cba11e70-27a7-4327-adeb-c483ab6018b7
Public Version Date: December 24, 2024
Public Version Number: 4
DI Record Publish Date: April 17, 2019