Closed Suction Catheters

FDA UDI

Class I (US FDA UDI)

by Ningbo Xinwell Medical Technology Co., Ltd.

Identity

Trade Name: Closed Suction Catheters FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: Closed Suction Catheters FDA UDI
Model / Reference: H110400 FDA UDI
Description: Closed Suction Catheters FDA UDI

Identifiers

Primary DI / UDI-DI: 06971944910165 FDA UDI
FDA Product Code: BSY FDA UDI
GMDN Term: Airway suction catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Airway suction catheter

Closed Suction Catheters by Ningbo Xinwell Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM 24 HOURS, SIZE 14F — Intersurgical Incorporated · Class I
ADULT ENDOTRACHEAL CLOSED SUCTION SYSTEM 24 HOURS, SIZE 16F — Intersurgical Incorporated · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ningbo Xinwell Medical Technology Co., Ltd.

Sources (1)

FDA UDI 371d833c-68fb-4fb0-a19e-0740e7245aac 33 fields · synced Jun 6, 2026