NuRoo

Basic Information

• Brand Name: NuRoo
• Primary DI: 00849174080001
• Version / Model: 08000
• Company Name: BROWNMED, INC.
• Labeler DUNS: 091999771
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-13
• Public Version: 2
• Public Version Date: 2020-09-28
• Public Version Status: Update
• Public Device Record Key: 25fdcfe8-d3cc-4acd-b215-855172458c25
• Distribution End Date: 2020-09-01

Device Description

Baby carrier

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEF	Binder, Breast	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60521	Neonatal kangaroo care garment	A non-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant in a manner which enables skin-to-skin contact between parent and infant (kangaroo care). It typically consists of a wrap/sweater with a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849174080001	GS1