AccessGUDID - DEVICE: Easy@Home Ovulation Test Strip (25 tests kit) (00810038630243)

GUDID

Device Identifier (DI) Information

Brand Name: Easy@Home Ovulation Test Strip (25 tests kit)
Version or Model: EZW2-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EZW2-S-25
Company Name: EASY HEALTHCARE CORPORATION

Primary DI Number: 00810038630243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 080278407 *Terms of Use

Device Description: 25 LH strips

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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
CEP	Radioimmunoassay, Luteinizing Hormone

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0d2ffa5a-c1ab-487b-a87f-7b8292c7ecff
Public Version Date: June 26, 2020
Public Version Number: 1
DI Record Publish Date: June 18, 2020