Axiom®

FDA UDI

Class II (US FDA UDI)

by Axiom Medical, Incorporated

Identity

Trade Name: Axiom® FDA UDI
Generic Name: Suction/irrigation tubing, single-use FDA UDI
Device Name: Non Sterile Continuous Tubing FDA UDI
Model / Reference: 515NS FDA UDI
Description: Non Sterile Continuous Tubing FDA UDI

Identifiers

Primary DI / UDI-DI: M665515NS0 FDA UDI
FDA Product Code: GAZ FDA UDI
GMDN Term: Suction/irrigation tubing, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Dimensions & Sizes

Size: Lumen/Inner Diameter — 0.5 Inch FDA UDI
Outer Diameter — 0.6875 Inch FDA UDI
Length — 50 Feet FDA UDI

Category: Suction/irrigation tubing, single-use

Axiom® by Axiom Medical, Incorporated — Class II — 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Axiom Medical, Incorporated

Sources (1)

FDA UDI af855124-6dcb-4cf4-a533-988dc4ffb3f2 35 fields · synced May 31, 2026