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.

Design Options® · Anesthesia Conduction Kit → Anesthesiology

Name: Design Options®
Brand: Design Options®

1manufacturer

12catalogue 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 Design Options®
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	2021-01-08 (version 6)

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	Storage environment temperature 20 to 25 °C
Distribution end date	2022-04-05

Catalogue Numbers

Catalogue numbers for Design Options®
Catalogue number	Size	Per pack	Status
570271		10	In distribution
552200		5	In distribution
570245	Gauge (Catheter) : 20	10	In distribution
570234		10	In distribution
570246	Gauge (cannula) : 18	10	In distribution
570205		10	In distribution
570269		10	In distribution
570296	Gauge (cannula) : 18	12	In distribution
570257		10	Withdrawn
570244	Gauge (Catheter) : 20	10	Withdrawn
570272	Gauge epidural needle : 18	10	Withdrawn
570224		10	Withdrawn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
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 Design Options®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
B. Braun Medical Inc.	UDI-DI	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.

Design Options®