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).

Accessories, Germicide, Cleaning, for Endoscopes → Gastroenterology & Urology

Name: Accessories, Germicide, Cleaning, For Endoscopes
Brand: Accessories, Germicide, Cleaning, For Endoscopes

1manufacturer

2catalogue numbers in this listing

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 Accessories, Germicide, Cleaning, For Endoscopes
Listed by	Pentax of America, Inc., United States
FDA product code	NZA
Device type	Accessories, Germicide, Cleaning, For Endoscopes
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K040049
Record published	2018-03-12
Record revised	2021-06-22 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Accessories, Germicide, Cleaning, For Endoscopes
Catalogue number	Size	Status
EPSC004INT		In distribution
EPSC001INT		In distribution

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
Reliance	Steris Corporation	1

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 Accessories, Germicide, Cleaning, For Endoscopes
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.

Accessories, Germicide, Cleaning, for Endoscopes