FDA.reportPublic FDA data

Medis

Primary DI
16920687303632
Brand
Medis
Company
Tianjin Medis Medical Device Co.,Ltd.
Model
ETT-X22-80
Catalog number
ETT-X22-80
Device description
Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 8.0
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190274000Endotracheal TubeTianjin Medis Medical Device Co., Ltd.2019-07-30BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16920687303632PackageGS110In Commercial Distribution
26920687303639PackageGS110In Commercial Distribution
06920687303635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692068730363216920687303632
2692068730363926920687303639
06920687303635069206873036356920687303635

GMDN Terms#

Term, Definition table
TermDefinition
Cuff-suction endotracheal tubeA hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8602283963862info@medis-medical.com

Regulatory Flags#

DUNS number
529125266
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06920687310411MedisNF404NF4042024-09-30
06920687310497MedisNF408NF4082024-09-30
06920687310510MedisNF409NF4092024-09-30
16920687310418MedisNF404NF4042024-09-30
16920687310494MedisNF408NF4082024-09-30
16920687310517MedisNF409NF4092024-09-30
06920687300146MedisNF1042023-09-07
06920687300153MedisNF1052023-09-07
06920687300160MedisNF1062023-09-07
06920687300177MedisNF1072023-09-07
06920687300184MedisNF1082023-09-07
06920687300191MedisNF1092023-09-07
06920687300207MedisNF2042023-09-07
06920687300214MedisNF2052023-09-07
06920687300221MedisNF2062023-09-07
06920687300238MedisNF2072023-09-07
06920687300245MedisNF2082023-09-07
06920687300252MedisNF2092023-09-07
06920687308432MedisNF4142023-09-07
06920687308449MedisNF4152023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750587KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750594KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750600KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750617KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750624KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750631KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750648KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750655KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750662KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750679KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750686KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750693KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27