AccessGUDID - DEVICE: Zzoma (00863826000315)

GUDID

Device Identifier (DI) Information

Brand Name: Zzoma
Version or Model: 001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 2Z Medical

Primary DI Number: 00863826000315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829477228 *Terms of Use

Device Description: The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).

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:	No
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?
35503	Sleep apnoea bed pillow	A specially designed cushion intended to support the head and neck (the cervical region) in a position that is similar to that used in cardiopulmonary resuscitation (CPR), so that the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnoea. It may also be used to help reduce snoring and improve the quality of sleep. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYB	Pillow,Cervical(For Mild Sleep Apnea)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100160	000

Device Exempt from Premarket Submission: No 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: 4d3454d1-dca1-4183-b9da-76776edf2e0e
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: November 11, 2016