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.

Anesthesiology › TherapeuticAnesthesia Conduction Kit

Sonolong Sono

Name: Sonolong Sono
Brand: Sonolong Sono

SonoLong Sono is a kit for continuous delivery of local anesthetic around peripheral nerves. An indwelling polyamide catheter carries the anesthetic for conduction anesthesia or analgesia…

Registry build 21.09.26

SonoLong Sono is a kit for continuous delivery of local anesthetic around peripheral nerves. An indwelling polyamide catheter carries the anesthetic for conduction anesthesia or analgesia for up to 72 hours. The kit provides needles and catheters used to establish and maintain that delivery route.

The Sono needles use surface features intended to improve their visibility under ultrasound. The catheters contain an inner coil that supports ultrasound visibility and stability. An electrical stimulus can optionally assist the physician in locating the area of application, depending on the configured components.

Listed Item

521187-31C

Kit Contents

The kits are supplied sterile for single use. Depending on configuration, additional components can include an adapter, syringe, filter and filter fixation device alongside the catheter and cannula.

1manufacturer

12catalogue 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 Sono
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	2021-07-07
Record revised	2025-12-01 (version 6)

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 temperature 10 to 30 °C; Storage environment humidity 10 to 65 % RH
Distribution end date	2025-06-17

Catalogue Numbers

Catalogue numbers for Sonolong Sono
Catalogue number	Per pack	Status
521187-31C	10	Withdrawn
521187-31B	10	Withdrawn
561187-31C	10	Withdrawn
531187-31A	10	Withdrawn
521187-31A	10	Withdrawn
521187-31B	10	Withdrawn
561187-31A	10	Withdrawn
561187-31C	10	Withdrawn
561187-31A	10	Withdrawn
521187-31A	10	Withdrawn
521187-31C	10	Withdrawn
531187-31A	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.