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

BD Epilor

Name: BD Epilor
Brand: BD Epilor

The BD Epilor is a 7 mL loss-of-resistance syringe used with an epidural needle to identify the epidural space. It works with air or liquid during the locating stage before epidural…

Registry build 21.09.26

The BD Epilor is a 7 mL loss-of-resistance syringe used with an epidural needle to identify the epidural space. It works with air or liquid during the locating stage before epidural medication delivery or catheter placement.

The syringe has a graduated polypropylene barrel, polypropylene plunger rod and a double-ribbed silicone stopper. Lubrication supports smooth plunger movement while the stopper helps prevent leakage.

Listed Item

Syringe Epilor Plastic LOR 7ML LS S/SU

Configurations

Luer lock and luer slip tip options connect to the needle. The syringe is intended for adult and pediatric epidural procedures and is not for spinal application. The family includes sterile and bulk nonsterile presentations, with the listed disposable unit supplied sterile.

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

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 BD Epilor
Listed by	Becton, Dickinson AND Company, United States
FDA product code	CAZ
Device type	Anesthesia Conduction Kit
Device class	Class 2
Regulation	21 CFR 868.5140
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K210983
Record published	2016-09-16
Record revised	2024-02-26 (version 5)

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	Case of 5, shelfpack of 10

Catalogue Numbers

Catalogue numbers for BD Epilor
Catalogue number	Size	Status
405292		In distribution
405291		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
K210983	2022-05-19

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.