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Xen Rinse 15G

FDA UDI

Class I (US FDA UDI)

by Quadralene Limited

Identity

Trade Name
Xen Rinse 15G FDA UDI
Generic Name
Instrument rinsing agent FDA UDI
Device Name
Rinse Additive for use in washer-disinfectors and cart washers. Steam and EtO permeable. FDA UDI
Model / Reference
XV1479/57NA FDA UDI
Description
Rinse Additive for use in washer-disinfectors and cart washers. Steam and EtO permeable. FDA UDI

Identifiers

Catalog Number
6036002301 FDA UDI
Primary DI / UDI-DI
05060478112242 FDA UDI
FDA Product Code
FLG FDA UDI
GMDN Term
Instrument rinsing agent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument rinsing agent

Xen Rinse 15G by Quadralene Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument rinsing agent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quadralene Limited

Sources (1)

  • FDA UDI fa81a1cb-db13-4e3d-8f78-c0b4b20ab952 34 fields · synced May 30, 2026