Xtreme

FDA UDI

Class I (US FDA UDI)

by Xtreme Personal Care Inc.

Identity

Trade Name: XTREME FDA UDI
Generic Name: Nasal lavage system FDA UDI
Device Name: "Nasal Irrigator with 2 nozzles 1200mA lithium battery cordless use 3 rinse modes for choice waterproof body water tank 200ml" FDA UDI
Model / Reference: CXN1-7000-WM1 FDA UDI
Description: "Nasal Irrigator with 2 nozzles 1200mA lithium battery cordless use 3 rinse modes for choice waterproof body water tank 200ml" FDA UDI

Identifiers

Catalog Number: Nasal Irrigator FDA UDI
Primary DI / UDI-DI: 00805106849603 FDA UDI
FDA Product Code: KAR FDA UDI
KMA FDA UDI
GMDN Term: Nasal lavage system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
874.5550 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nasal lavage system

Xtreme by Xtreme Personal Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Hydrodebrider® — MEDTRONIC XOMED, INC. · Class I
SinuPulse — HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP. · Class I
Hydrodebrider® — MEDTRONIC XOMED, 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: Xtreme Personal Care Inc.

Sources (1)

FDA UDI 93b3644f-356f-41c7-8a53-76a547f425de 35 fields · synced May 30, 2026