What is FDA product code CAZ?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Sonolong Echo · Anesthesia Conduction Kit → Anesthesiology

Name: Sonolong Echo
Brand: Sonolong Echo

1manufacturer

26catalogue numbers in this listing

8510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code CAZ
Manufacturer	City	Province	Registered as	Device types
Jiangsu Caina Medical Co., Ltd.	Jiangyin	Jiangsu	Contract manufacturer	20

Record

Regulatory record for Sonolong Echo
Listed by	Pajunk Gmbh Medizintechnologie, Germany
FDA product code	CAZ
Device type	Anesthesia Conduction Kit
Device class	Class 2
Regulation	21 CFR 868.5140
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer
510(k)	K113188
Record published	2021-04-02
Record revised	2025-12-01 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment humidity 10 to 65 % RH; Storage environment temperature 10 to 30 °C
Distribution end date	2026-07-17

Catalogue Numbers

Catalogue numbers for Sonolong Echo
Catalogue number	Per pack	Status
521185-31CU	10	Withdrawn
511185-31A	10	Withdrawn
511185-31C	10	Withdrawn
531185-31C	10	Withdrawn
521185-31C	10	Withdrawn
531185-31B	10	Withdrawn
561185-31A	10	Withdrawn
531185-31C	10	Withdrawn
521185-31A	10	Withdrawn
521165-31C	10	Withdrawn
521185-31B	10	Withdrawn
531185-31A	10	Withdrawn
531185-31B	10	Withdrawn
521185-31CU	10	Withdrawn
521185-31A	10	Withdrawn
531185-31CU	10	Withdrawn
561185-31C	10	Withdrawn
531185-31A	10	Withdrawn
561185-31A	10	Withdrawn
521165-31C	10	Withdrawn
561185-31C	10	Withdrawn
531185-31CU	10	Withdrawn
511185-31C	10	Withdrawn
521185-31B	10	Withdrawn
521185-31C	10	Withdrawn
511185-31A	10	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Portex	ICU Medical, Inc	1,340
Arrow	Teleflex Medical LLC	508
Halyard	Avanos Medical, Inc.	422
Avanos	Avanos Medical, Inc.	315
Busse Hospital Disposables	Robert Busse & Co., Inc.	215
Integra®	Integra Pain Management	181
Epilong	Pajunk Gmbh Medizintechnologie	79
BD Perisafe, BD Epilor, BD Luer-Lok	Becton, Dickinson AND Company	44
Temena	Temena GmbH	44
BD Luer-Lok, BD Glaspak	Becton, Dickinson AND Company	36
Contiplex®	B. Braun Medical Inc.	34
Stimulong Sono	Pajunk Gmbh Medizintechnologie	27

Showing 12 of 109. All products under Anesthesia Conduction Kit

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K202699	2020-12-29
K190345	2019-05-16
K113188	2012-03-01
K082183	2008-10-28
K082164	2008-10-27
K062902	2007-06-07
K062900	2007-01-12
K060311	2006-06-13

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.

Sonolong Echo