What is FDA product code OEZ?

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 › DiagnosticCardiovascular Procedure Kit

Mycordella Patient Kit

Name: myCordella Patient Kit
Brand: myCordella Patient Kit

myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display screen that assists patients with obtaining vital sign…

Registry build 21.09.26

myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to doctors • Provides secure communication between patient and doctor • Provides access to patient education materials • Facilitates review of past measurements • Facilitates review of patient goals myCordella Peripherals Medical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OEZ
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for myCordella Patient Kit
Listed by	Endotronix, Inc.
FDA product code	OEZ
Device type	Cardiovascular Procedure Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Premarket notification	Exempt
Record published	2024-08-13
Record revised	2026-03-17 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	serial number
Storage	Storage environment temperature -10 to 45 °C; Storage environment humidity 10 to 95 % RH
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for myCordella Patient Kit
Catalogue number	Size	Status
100171-00		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	40,731
Medline Industries, Inc.	Medline Industries, Inc.	17,468
Avid TruCustom	Avid Medical, Inc.	2,785
Namic	Medline Industries, Inc.	2,718
Merit Medical®	Merit Medical Systems, Inc.	2,399
Halyard	Avid Medical, Inc.	2,108
ACS	American Contract Systems, Inc.	1,540
Medline	Medline Industries, Inc.	428
Stradis Healthcare	Stradis Healthcare	263
Regard™	ROi CPS LLC	192
Stradis	Stradis Healthcare	108
Regard™	Resource Optimization & Innovation, L.L.C.	72

Showing 12 of 52. All products under Cardiovascular Procedure 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.