AccessGUDID - DEVICE: DREAMIES (00860008980793)

GUDID

Device Identifier (DI) Information

Brand Name: DREAMIES
Version or Model: Size XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NEAT004-05
Company Name: NEATCAP MEDICAL LLC

Primary DI Number: 00860008980793
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075105568 *Terms of Use

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 XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® devices are packaged non-sterile.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWE	Protector, Hearing (Circumaural)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 652dcbf8-66da-4cf5-8d67-1155e5ae8531
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022