What is FDA product code OEQ?

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.

Cardiovascular › DiagnosticAngiography/Angioplasty Kit

Necessities Kit

Name: Necessities Kit
Brand: Necessities Kit

Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) 0.009 - 0.018" Guidewire Torque Device

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OEQ
Manufacturer	City	Province	Registered as	Device types
Elite Medtek(Jiangsu) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	9
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10

Record

Regulatory record for Necessities Kit
Listed by	Remington Medical, Inc., United States
FDA product code	OEQ
Device type	Angiography/Angioplasty Kit
Device class	Class 2
Regulation	21 CFR 870.1650
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2018-11-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Shipping carton of 12, inner carton of 10
Sizes	Catheter gauge 9 Fr

Catalogue Numbers

Catalogue numbers for Necessities Kit
Catalogue number	Size	Status
NK-01	Catheter Gauge 9 Fr	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	20,409
Merit Medical®	Merit Medical Systems, Inc.	3,927
Medline Industries, Inc.	Medline Industries, Inc.	2,085
ACS	American Contract Systems, Inc.	428
DeRoyal	Deroyal Industries, Inc.	283
Aligned Medical Solutions	Aligned Medical Solutions	120
Regard™	ROi CPS LLC	57
Stradis Healthcare	Stradis Healthcare	33
Regard™	Resource Optimization & Innovation, L.L.C.	23
Namic	Medline Industries, Inc.	21
basixCOMPAK™	Merit Medical Systems, Inc.	8
Stradis	Stradis Healthcare	7

Showing 12 of 49. All products under Angiography/Angioplasty 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.