Sample Processing kits for Urine/Fecal Analysis

Basic Information

• Brand Name: Sample Processing kits for Urine/Fecal Analysis
• Primary DI: 06975679490251
• Version / Model: YH-HC510
• Company Name: Hunan Ehome Health Technology Co., Ltd.
• Labeler DUNS: 550468087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-10
• Public Version: 1
• Public Version Date: 2025-10-20
• Public Version Status: New
• Public Device Record Key: 5b973386-10dc-4c87-bf4f-dce614ee5436

Device Description

Sample Processing kits for Urine/Fecal Analysis,Each primary package of device count :20T

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.	No	Active
65921	Faecal specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use for the sampling and containment of a small, predetermined amount of faecal matter from a primary faecal specimen, for subsequent laboratory analysis and/or other investigation. It typically consists of a specimen container (e.g., tube with a cap) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium, extraction buffer), and a sampling tool (e.g., swab, brush or spatula). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975679490251	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat