DEVICE: Zzoma (00863826000315)

Device Identifier (DI) Information

Zzoma
001
In Commercial Distribution

2Z Medical
00863826000315
GS1

1
829477228 *Terms of Use
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sleep apnoea pillow A specially designed cushion used 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.
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FDA Product Code

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

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4d3454d1-dca1-4183-b9da-76776edf2e0e
March 29, 2018
2
November 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
877 799 9662
info@2zmedical.com
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