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

Prolong* Continuous Nerve Block Set

Name: Prolong* Continuous Nerve Block Set
Brand: Prolong* Continuous Nerve Block Set

6 catalogue numbers from 32772, listed by Avanos Medical, Inc., United States, under Anesthesia Conduction Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

6catalogue numbers in this listing

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 Prolong* Continuous Nerve Block Set
Listed by	Avanos Medical, Inc., United States
FDA product code	CAZ
Device type	Anesthesia Conduction Kit
Device class	Class 2
Regulation	21 CFR 868.5140
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2020-07-03
Record revised	2024-02-05 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 10
Sizes	Needle gauge 18 to 19 G

Catalogue Numbers

Catalogue numbers for Prolong* Continuous Nerve Block Set
Catalogue number	Size	Status
32772	Needle Gauge 19 G	In distribution
38604	Needle Gauge 19 G	In distribution
32774	Needle Gauge 18 G	In distribution
32775	Needle Gauge 18 G	In distribution
32771	Needle Gauge 19 G	In distribution
32776	Needle Gauge 18 G	In distribution

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

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.