Who else makes this device?

Name: Membrane for E722 electrode
Brand: Membrane for E722 electrode

Membrane for E722 Electrode · Electrode, Ion Specific, Potassium → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

3recalls on this code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code CEM
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for Membrane for E722 electrode
Listed by	Radiometer Medical APS, Denmark
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
Establishment	Complaint-file establishment, Manufacturer
Record published	2016-09-01
Record revised	2020-11-27 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 32 °C

Catalogue Numbers

Catalogue numbers for Membrane for E722 electrode
Catalogue number	Size	Per pack	Status
942-059		4	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nova	Nova Biomedical Corporation	8
Stat Profile	Nova Biomedical Corporation	7
Potassium electrode	Roche Diagnostics Gmbh	4
Potassium Electrode	Diamond Diagnostics Inc.	3
Synermed®	Infrared Laboratory Systems LLC	3
Architect	Abbott Laboratories	3
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	2
I.S.E. K	Randox Laboratories Limited	2
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Potassium Electrode	Medica Corp.	2
Na/K Solution Pack	Medica Corp.	2
Selectra	VitalScientific B.V.	2

Showing 12 of 93. All products under Electrode, Ion Specific, Potassium

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K092686	2010-08-06

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-04-14	Class II	Device Design	Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.	Total 965 PC units World-wide (only 35 units in the U.S.)
2021-04-14	Class II	Device Design	Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.	Total=3,346 analyzers world-wide (only 2 analyzers within th
2020-02-03	Class II	Software design	The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. T	12,822 units	2022-09-20

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.

Membrane for E722 Electrode