FDA.reportPublic FDA data

Medis

Primary DI
06920687303611
Brand
Medis
Company
Tianjin Medis Medical Device Co.,Ltd.
Model
ETT-X22-70
Catalog number
ETT-X22-70
Device description
Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 7.0
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
16920687303618PackageGS110In Commercial Distribution
26920687303615PackageGS110In Commercial Distribution
06920687303611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692068730361816920687303618
2692068730361526920687303615
06920687303611069206873036116920687303611

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 Diameter7Millimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
529125266
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750709KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750716KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750723KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750730KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
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00810003750815KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
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