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Medis

FDA UDI

Class II (US FDA UDI)

by Tianjin Medis Medical Device Co., Ltd.

Identity

Trade Name
Medis FDA UDI
Generic Name
Cuff-suction endotracheal tube FDA UDI
Device Name
Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 9.0 FDA UDI
Model / Reference
ETT-X22-90 FDA UDI
Description
Endotracheal Tube,With Subglottic Suction Port and HVLP Cuff 9.0 FDA UDI

Identifiers

Catalog Number
ETT-X22-90 FDA UDI
Primary DI / UDI-DI
06920687303659 FDA UDI
510(k) Number
K190274 FDA UDI
FDA Product Code
BTR FDA UDI
GMDN Term
Cuff-suction endotracheal tube FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Inner Diameter — 9.0 Millimeter FDA UDI

Category: Cuff-suction endotracheal tube

Medis by Tianjin Medis Medical Device Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cuff-suction endotracheal tube.

Cleared under the same submission

K190274 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tianjin Medis Medical Device Co., Ltd.

Sources (1)

  • FDA UDI 3d6fe183-c041-4a91-8637-5689dc9ad039 38 fields · synced May 31, 2026