Well Lead Endotracheal Tube with Evacuation Lumen

GUDID 16944932737003

PVC Cuff 9.0

Well Lead Medical Co.,Ltd

Basic endotracheal tube, single-use
Primary Device ID16944932737003
NIH Device Record Key32880d4a-d5d8-4cf6-9f57-bd6369941b24
Commercial Distribution StatusIn Commercial Distribution
Brand NameWell Lead Endotracheal Tube with Evacuation Lumen
Version Model NumberA01F019010
Company DUNS544811862
Company NameWell Lead Medical Co.,Ltd
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944932737006 [Primary]
GS116944932737003 [Package]
Contains: 06944932737006
Package: Box [10 Units]
In Commercial Distribution
GS126944932737000 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-05
Device Publish Date2024-01-27

On-Brand Devices [Well Lead Endotracheal Tube with Evacuation Lumen]

16944932737003PVC Cuff 9.0
16944932730448PVC Cuff 6.5
16944932730431PVC Cuff 6.0
16944932729664PVC Cuff 8.5
16944932729657PVC Cuff 8.0
16944932729640PVC Cuff 7.5
16944932729633PVC Cuff 7.0

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