NuRoo

Basic Information

• Brand Name: NuRoo
• Primary DI: 00082161082811
• Version / Model: 08281
• 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: be215a36-b558-4f2f-9d74-900891c7d2b3
• Distribution End Date: 2020-09-01

Device Description

Baby swaddle

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
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10417	Infant blanket, reusable	A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00082161082811	GS1