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.

Graftsite · Anesthesia Conduction Kit → Anesthesiology

Name: Graftsite
Brand: Graftsite

1manufacturer

1catalogue number

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 Graftsite
Listed by	Summit Medical LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K173110
Record published	2018-12-21
Record revised	2019-07-04 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Cardboard carton of 5, box of 25

Catalogue Numbers

Catalogue numbers for Graftsite
Catalogue number	Size	Status
D201045		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.

Graftsite

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies