Remotely controlled mandibular positioner (MATRx)

GUDID B406CKT000000300100

Zephyr Sleep Technologies Inc

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDB406CKT000000300100
NIH Device Record Key240e4149-6f63-4432-8425-7b3834b310a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemotely controlled mandibular positioner (MATRx)
Version Model NumberZ10-005-1.0
Company DUNS245252833
Company NameZephyr Sleep Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-341-8814
Emailsupport@zephyrsleep.com
Phone1-877-341-8814
Emailsupport@zephyrsleep.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB406CKT000000300100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-02

Devices Manufactured by Zephyr Sleep Technologies Inc

B406CAT024030 - MATRx Plus2019-11-08
B406CAT024020 - MATRx plus2019-05-24
B406CAT024010 - MATRx plus2018-11-30
B406CKT000000300100 - Remotely controlled mandibular positioner (MATRx)2018-07-06
B406CKT000000300100 - Remotely controlled mandibular positioner (MATRx)2018-07-06

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