DREAMIES T-M

Basic Information

• Brand Name: DREAMIES T-M
• Primary DI: 00860008980700
• Version / Model: Size XS
• Catalog Number: NEAT005-01
• 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: 793b3f75-a2e7-4dc4-a499-e01fe5816519

Device Description

The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® T-M 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: MR Safe
• 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	00860008980700	GS1

Customer Contacts

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