Medis ETT-P22-80

GUDID 16920687301003

Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 8.0

Tianjin Medis Medical Device Co.,Ltd.

Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use
Primary Device ID16920687301003
NIH Device Record Key56bc3104-ee61-473c-9c99-0b2822e293d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedis
Version Model NumberETT-P22-80
Catalog NumberETT-P22-80
Company DUNS529125266
Company NameTianjin Medis Medical Device Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+8602283963862
Emailinfo@medis-medical.com
Phone+8602283963862
Emailinfo@medis-medical.com
Phone+8602283963862
Emailinfo@medis-medical.com

Device Dimensions

Catheter Inner Diameter8 Millimeter
Catheter Inner Diameter8 Millimeter
Catheter Inner Diameter8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106920687301006 [Primary]
GS106920687301006 [Primary]
GS106920687301006 [Primary]
GS116920687301003 [Package]
Contains: 06920687301006
Package: Inner Box [10 Units]
In Commercial Distribution
GS116920687301003 [Package]
Contains: 06920687301006
Package: Inner Box [10 Units]
In Commercial Distribution
GS116920687301003 [Package]
Contains: 06920687301006
Package: Inner Box [10 Units]
In Commercial Distribution
GS126920687301000 [Package]
Package: Carton [10 Units]
In Commercial Distribution
GS126920687301000 [Package]
Package: Carton [10 Units]
In Commercial Distribution
GS126920687301000 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)
BTRTube, Tracheal (W/Wo Connector)
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 Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Medis]

16920687303656Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 9.0
16920687303632Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 8.0
16920687303625Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 7.5
16920687303618Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 7.0
16920687303595Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 6.0
16920687301478Endotracheal Tube,Reinforced, Oral/Nasal with HVLP Cuff 9.0
16920687301454Endotracheal Tube,Reinforced, Oral/Nasal with HVLP Cuff 8.0
16920687301430Endotracheal Tube,Reinforced, Oral/Nasal with HVLP Cuff 7.0
16920687301416Endotracheal Tube,Reinforced, Oral/Nasal with HVLP Cuff 6.0
16920687301027Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 9.0
16920687301003Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 8.0
16920687300990Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 7.5
16920687300983Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 7.0
16920687300976Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 6.5
16920687300969Endotracheal Tube,Standard, Oral/Nasal with HVLP Cuff 6.0

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.