Endotracheal Tube with Evacuation Lumen

GUDID 16944932784106

PU Cuff 8.0 DEHP FREE

Well Lead Medical Co.,Ltd

Basic endotracheal tube, single-use
Primary Device ID16944932784106
NIH Device Record Key86794308-9ce9-4aeb-8489-89632d3d3aad
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndotracheal Tube with Evacuation Lumen
Version Model NumberA01G04804F
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
GS106944932784109 [Primary]
GS116944932784106 [Package]
Contains: 06944932784109
Package: Box [10 Units]
In Commercial Distribution
GS126944932784103 [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 [Endotracheal Tube with Evacuation Lumen]

16944932784144PU Cuff 9.0 DEHP FREE
16944932784120PU Cuff 8.5 DEHP FREE
16944932784106PU Cuff 8.0 DEHP FREE
16944932784083PU Cuff 7.5 DEHP FREE
16944932784069PU Cuff 7.0 DEHP FREE
16944932784045PU Cuff 6.5 DEHP FREE
16944932784021PU Cuff 6.0 DEHP FREE
16944932774923PVC DEHP Free Cuff 9.0
16944932774909PVC DEHP Free Cuff 8.5
16944932774886PVC DEHP Free Cuff 8.0
16944932774862PVC DEHP Free Cuff 7.5
16944932774848PVC DEHP Free Cuff 7.0
16944932774824PVC DEHP Free Cuff 6.5
16944932774800PVC DEHP Free Cuff 6.0

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