Breathe-EZ

GUDID 00858276007755

Breathe-EZ

Micro-tech Usa

Endoscopic bite block, basic, single-use
Primary Device ID00858276007755
NIH Device Record Key474d0776-1258-4d11-a3e5-685310bcc31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreathe-EZ
Version Model NumberMDBB1AY002A
Company DUNS079873914
Company NameMicro-tech Usa
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858276007748 [Primary]
GS100858276007755 [Package]
Contains: 00858276007748
Package: Box [50 Units]
In Commercial Distribution
GS100858276007762 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

MNKEndoscopic Bite Block

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

On-Brand Devices [Breathe-EZ]

00858276007755Breathe-EZ
00850025860048Breathe-EZ Bite Bloc Adult 60Fr Elastic

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.