Who else makes this device?

Name: Valve Module (unheated)
Brand: Valve Module (unheated)

Valve Module (Unheated) · Electrode, Ion Specific, Potassium → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

2recalls 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 Valve Module (unheated)
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K000926
Record published	2016-09-24
Record revised	2021-11-19 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Valve Module (unheated)
Catalogue number	Size	Status
10309056		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

Recalls

1 of these is 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
2015-02-24	Class II	Under Investigation by firm	A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not det	5981	2017-02-01
2010-08-19	Not classified	Other	High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.	3,706 cartons	2010-10-26

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.

Valve Module (Unheated)