Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name: Bioseal Inc. FDA UDI
Generic Name: Suction/irrigation tubing, single-use FDA UDI
Device Name: Silicone Tubing Ped 2 3/4" FDA UDI
Model / Reference: 19761/100 FDA UDI
Description: Silicone Tubing Ped 2 3/4" FDA UDI

Identifiers

Primary DI / UDI-DI: 00630094197616 FDA UDI
FDA Product Code: GCY FDA UDI
GMDN Term: Suction/irrigation tubing, single-use 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: Suction/irrigation tubing, single-use

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

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Also classified as Suction/irrigation tubing, single-use.

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ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
BHL-SuctionCare — BHL-Medical, Indústria de Produtos Hospitalares, lda · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II

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 04328e63-49e1-4583-b396-7b4d7dcb40bd 33 fields · synced May 30, 2026