AccessGUDID - DEVICE: Conception Kit (00895863001000)

GUDID

Device Identifier (DI) Information

Brand Name: Conception Kit
Version or Model: CX-0002-ML EN/ES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CX-0002-ML EN/ES
Company Name: CONCEIVEX INC.

Primary DI Number: 00895863001000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 610032034 *Terms of Use

Device Description: Lot number, Expiration Date, Individual Kit Number, Temperature Range and the statement: The Conception Kit should be kept away from direct sunlight, moisture and heat.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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
OBB	Kit, Conception-Assist, Home Use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 35 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Wide 9 inches
Device Size Text, specify: lenght 10 inches
Device Size Text, specify: Height: 6 .5 inches

Device Record Status

Public Device Record Key: f4f509b2-c2d8-4952-80c6-fc6b66397f49
Public Version Date: February 21, 2019
Public Version Number: 2
DI Record Publish Date: September 01, 2018