TensCare

Basic Information

• Brand Name: TensCare
• Primary DI: 05033435135776
• Version / Model: Nouri Duo
• Catalog Number: K00147
• Company Name: TENSCARE LIMITED
• Labeler DUNS: 569403736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: 50c318f8-ab3e-4391-a47b-194851fbc4ee

Device Description

The Nouri Digital Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38478	Breast pump, electric	A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05033435135776	GS1