Premom Ovulation Cassette Kit (30 LH + 10 HCG) PMC-3010

GUDID 10855944007199

Premom 30 LH Ovulation Cassettes and 10 HCG Pregnancy Cassettes Kit (30 LH + 10 HCG)

EASY HEALTHCARE CORPORATION

Natural conception assistance kit
Primary Device ID10855944007199
NIH Device Record Keyc37f6da9-4937-4b2a-96b4-9c23cdf1b6fc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremom Ovulation Cassette Kit (30 LH + 10 HCG)
Version Model NumberPM2-C, PM1-C
Catalog NumberPMC-3010
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count40
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100855944007192 [Primary]
GS110855944007199 [Package]
Contains: 00855944007192
Package: Carton [54 Units]
In Commercial Distribution
GS130855944007193 [Unit of Use]

FDA Product Code

CEPRadioimmunoassay, Luteinizing Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-21
Device Publish Date2018-07-01

Devices Manufactured by EASY HEALTHCARE CORPORATION

10810038636846 - Easy@Home Pregnancy Test (5 tests) 2024-11-18 Easy@Home Pregnancy Test (5 tests)
10810038636266 - Easy@Home Blood Pressure Monitor 2024-11-12
10810038636990 - Areta Multi-Drug Test Cup (25 tests kit)2024-10-08 Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
10810038636549 - Easy@Home Pregnancy Test2024-10-04 Easy@Home Pregnancy Test
40810038636434 - Easy@Home Multi-Drug Screen Test (5 tests kit)2024-07-25 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
20810038636447 - Easy@Home Nicotine Urine Test (5 tests one kit)2024-07-25 5 tests kit; Nicotine Urine Test -COT
10810038636488 - Premom Smart Basal Thermometer2024-05-20
10810038636129 - Easy@Home Adhesive Electrode Pads2024-04-23

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.