AccessGUDID - DEVICE: Kroger (00041260351594)

GUDID

Device Identifier (DI) Information

Brand Name: Kroger
Version or Model: One Step Ovulation Predictor
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KROGER CO., THE

Primary DI Number: 00041260351594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 7
Labeler D-U-N-S® Number*: 006999528 *Terms of Use

Device Description: WWOT Kroger Ovulation 7Ct

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f78ed767-7e69-43bf-bce6-b26408ec10fc
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10041260378314	24	00041260351594		In Commercial Distribution	Shipping case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00633472000140 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-632-6900
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES