BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

H.E.B

DI: 00041220103164 · Model: One Step Ovulation Predictor · H. E. BUTT GROCERY COMPANY

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

7

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Basic Information

Brand Name: H.E.B
Primary DI: 00041220103164
Version / Model: One Step Ovulation Predictor
Company Name: H. E. BUTT GROCERY COMPANY
Labeler DUNS: 007924756
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 7
Record Status: Published
Publish Date: 2019-02-06
Public Version: 2
Public Version Date: 2020-12-15
Public Version Status: Update
Public Device Record Key: 32b7961a-8b9f-402c-9478-23abbb2a522f
Distribution End Date: 2020-12-14

Device Description

WWOT HEB Ovulation

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
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: Yes
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	Medical Specialty	Regulation #	Device Class
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	862.1485	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00041220103164	GS1
Unit of Use	00633472000140	GS1
Package	00141220103161	GS1	Shipping Case	24	Not in Commercial Distribution	2020-12-14

Customer Contacts

Phone: 1-800-899-7353
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 2 – 30 Degrees Celsius