DREAMIES

Basic Information

• Brand Name: DREAMIES
• Primary DI: 00860008980786
• Version / Model: Size LG
• Catalog Number: NEAT004-04
• Company Name: NEATCAP MEDICAL LLC
• Labeler DUNS: 075105568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: eb96c373-8730-4b9c-a2e2-d407adea3997

Device Description

The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size LG device is designed for use on infants with a head circumference measuring 35-41cm. NEATCAP® DREAMIES® devices are packaged non-sterile.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWE	Protector, Hearing (Circumaural)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63512	Infant acoustic earmuffs	A device consisting of two ear-covering cups (one for each ear) intended to provide noise insulation for neonates/infants in a special care unit. The cups are typically lined with sound attenuating material and held in place by hydrocolloid/hydro gel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008980786	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]