Trachsealtm Adult Tracheostomy Closed Suction System With Nacl Ampoules, 24 Hour

FDA UDI

Class I (US FDA UDI)

by Intersurgical Incorporated

Identity

Trade Name: TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F16. PROCEDURE PACK FDA UDI
Model / Reference: 3241007 FDA UDI
Description: TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F16. PROCEDURE PACK FDA UDI

Identifiers

Primary DI / UDI-DI: 05030267153671 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

Trachsealtm Adult Tracheostomy Closed Suction System With Nacl Ampoules, 24 Hour by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID

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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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Little Sucker Standard TP — Neotech Products LLC · Class II
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 922a4698-8f52-48b9-829f-b3c8aff524a0 34 fields · synced Jun 1, 2026