FDA UDI In Commercial Distribution 🇺🇸 United States

Premom Ovulation Tests (40 LH strips + 10 HCG strips )

DI: 00810038630458 · Model: PMS2-S, PMS1-S · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
Premom Ovulation Tests (40 LH strips + 10 HCG strips )
Primary DI
00810038630458
Version / Model
PMS2-S, PMS1-S
Catalog Number
PMS-4010
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2023-04-12
Public Version
1
Public Version Date
2023-04-20
Public Version Status
New
Public Device Record Key
be62fd79-5c8e-445f-98e8-8e0fa082105d

Device Description

40 LH strips + 10 HCG strips ;Ovulation Test Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
NGE Test, Luteinizing Hormone (Lh), Over The Counter

GMDN Terms

Code Name
60862 Natural conception assistance kit

Identifiers

Type ID
Package 10810038630455
Primary 00810038630458
Unit of Use 30810038630459