Otomed® Suction Tubing

FDA UDI

Class I (US FDA UDI)

by Oto-Med, Inc.

Identity

Trade Name: OTOMED® SUCTION TUBING FDA UDI
Generic Name: Suction/irrigation tubing, single-use FDA UDI
Device Name: OTOMED® SUCTION TUBING FDA UDI
Model / Reference: SP-4000 FDA UDI
Description: OTOMED® SUCTION TUBING FDA UDI

Identifiers

Primary DI / UDI-DI: 00850000126121 FDA UDI
FDA Product Code: GBX FDA UDI
GMDN Term: Suction/irrigation tubing, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 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

FDA UDI

Category: Suction/irrigation tubing, single-use

Otomed® Suction Tubing by Oto-Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
Bioseal Inc. — BIOSEAL · Class I
Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
Bioseal Inc. — BIOSEAL · 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: Oto-Med, Inc.

Sources (1)

FDA UDI 53bb1465-026b-4eac-8a88-d5806ab4594e 34 fields · synced Jun 8, 2026