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.

Anesthesia Support Tray · Anesthesia Conduction Kit → Anesthesiology

Name: Anesthesia Support Tray
Brand: Anesthesia Support Tray

1manufacturer

4catalogue numbers in this listing

7510(k) clearances naming this product code

1recall

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 Anesthesia Support Tray
Listed by	B. Braun Medical Inc., United States
FDA product code	CAZ
Device type	Anesthesia Conduction Kit
Device class	Class 2
Regulation	21 CFR 868.5140
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-23
Record revised	2020-04-27 (version 5)

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
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature 1 to 40 °C; Storage environment temperature 20 to 25 °C

Catalogue Numbers

Catalogue numbers for Anesthesia Support Tray
Catalogue number	Per pack	Status
332114	10	In distribution
332116	10	In distribution
332112	10	In distribution
332115	10	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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K113059	2012-01-24
K090995	2009-08-14
K063282	2007-06-20
K033952	2004-02-04
K032144	2003-10-01
K971233	1997-10-17
K962696	1997-04-03

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Anesthesia Support Tray
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Mckesson Medical-Surgical Inc. Corporate Office	UDI-DI	2022-05-25	Class II	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.	16 cases

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-01-29	Class II	Process control	B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p	210

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.

Anesthesia Support Tray