Trachseal Adult Trach Closed Suction With Saline 24hr F10

FDA UDI

Class I (US FDA UDI)

by Intersurgical Incorporated

Identity

Trade Name: TRACHSEAL ADULT TRACH CLOSED SUCTION WITH SALINE 24HR F10 FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: TRACHSEAL ADULT TRACH CLOSED SUCTION WITH SALINE 24HR F10 FDA UDI
Model / Reference: 3241004 FDA UDI
Description: TRACHSEAL ADULT TRACH CLOSED SUCTION WITH SALINE 24HR F10 FDA UDI

Identifiers

Primary DI / UDI-DI: 05030267153640 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

Yes

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Airway suction catheter

Trachseal Adult Trach Closed Suction With Saline 24hr F10 by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Airway suction catheter.

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Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
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Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · 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: Intersurgical Incorporated

Sources (1)

FDA UDI 8528cefb-9f0d-4d62-8f65-d2df756e8eda 34 fields · synced May 30, 2026