Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name: Bioseal Inc. FDA UDI
Generic Name: Airway suction catheter FDA UDI
Device Name: Suction Catheter FDA UDI
Model / Reference: 4916/20 FDA UDI
Description: Suction Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 00630094049168 FDA UDI
FDA Product Code: GCY FDA UDI
GMDN Term: Airway suction catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4680 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Airway suction catheter

Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Airway suction catheter.

AirLife™ — Airlife, Inc. · 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
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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: Bioseal

Sources (1)

FDA UDI 79188dc7-3b0f-4a39-a3d5-76d27e526254 33 fields · synced Jun 1, 2026