What is FDA product code NZA?

High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticAccessories, Germicide, Cleaning, For Endoscopes

Reliance

Name: Reliance
Brand: Reliance

The Reliance DG Dry Germicide is a single-use dry germicide used only in the Reliance EPS Endoscope Processing System. The net contents are 272g per cup.

Registry build 21.09.26

1manufacturer

1catalogue number

9510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NZA
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Reliance
Listed by	Steris Corporation, United States
FDA product code	NZA
Device type	Accessories, Germicide, Cleaning, For Endoscopes
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K040049
Record published	2016-09-08
Record revised	2025-04-30 (version 15)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 16 to 27 °C; Storage environment humidity 10 to 60 % RH; Special storage condition: Keep upright, dry, and in a clean environment. Avoid extreme heat and humidity
Packaging	Case of 4
Distribution end date	2025-04-29

Catalogue Numbers

Catalogue numbers for Reliance
Catalogue number	Size	Per pack	Status
D5100		5	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Accessories, Germicide, Cleaning, For Endoscopes	Corporation Steris Canada	11
Reliance	Corporation Steris Canada	6
Accessories, Germicide, Cleaning, For Endoscopes	Pentax of America, Inc.	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232918	2023-10-03
K230560	2023-07-21
K220361	2022-03-10
K203223	2021-01-28
K200989	2020-05-14
K123768	2013-07-26
K110453	2011-03-16
K102244	2010-12-03
K040049	2004-12-17

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Reliance
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Steris Corporation	510(k) number	2013-08-29	Class II	Use error	The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection	266 units	2014-07-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.