Mouthpiece, Smooth 22mm

GUDID 00709078002700

Mouthpiece, Smooth 22mm, Bulk, (700/Cs)

WESTMED, INC.

Breathing mouthpiece, single-use
Primary Device ID00709078002700
NIH Device Record Key1678a6c3-38d5-4f0e-b4f5-edc0e7023a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameMouthpiece, Smooth 22mm
Version Model Number0429
Company DUNS092673953
Company NameWESTMED, INC.
Device Count700
DM Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078002700 [Primary]
GS100709078002786 [Unit of Use]

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2017-02-20

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