FDA.report

Membrane for E722 electrode

Primary DI
05700699420596
Brand
Membrane for E722 electrode
Company
Radiometer Medical ApS
Model
942-059
Catalog number
942-059
Device description
D722 K membrane box (4 units) for ABL7XX/8XX
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM

Product Code Classifications

CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05700699420596PrimaryGS10
55700699420591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05700699420596057006994205965700699420596
5570069942059155700699420591

GMDN Terms

TermDefinition
Potassium (K+) IVD, kit, ion-selective electrode (ISE)A collection of reagents and other associated materials intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen, using an ion-selective electrode (ISE) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius32 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags

DUNS number
308667539
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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55700699428757CLINITUBES D941G-240-85X5942-875942-8752022-12-05
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55700699428825CLINITUBES D941G-80-140X5942-882942-8822022-12-05
55700699428849CLINITUBES D957G-70-210X5942-884942-8842022-12-05
55700699428856D941G-240-55X5942-885942-8852022-12-05
55700699428894SafeClinitube D941P-NA-240-55942-889942-8892022-12-05
55700699428900SAFE CLINIT. D941P-240-85X1942-890942-8902022-12-05
55700699428917SAFE CLINIT. D941P-NA-240-85X3942-891942-8912022-12-05
55700699428924SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06936415904661MR Na/K Check SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.CEM2026-01-23
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07613336227770Potassium electrodeRoche Diagnostics GmbHCEM2025-03-05
07613336227794Reference electrodeRoche Diagnostics GmbHCEM2025-03-05
07640172344002FlexLab XInpeco SACEM2024-07-30
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSCEM2024-07-01
03661540304156Potassium ElectrodeELITECHGROUP INC.CEM2023-10-01
00811403012558Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-12
00811403015931Sample DetectorDiamond Diagnostics Inc.CEM2023-06-06
00811403015948Membrane AssemblyDiamond Diagnostics Inc.CEM2023-06-06
00811403010127Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403015788Potassium ElectrodeDiamond Diagnostics Inc.CEM2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.CEM2023-06-05
04015630028689Roche 9180 Potassium electrodeRoche Diagnostics GmbHCEM2021-07-30
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04580262010277K ElectrodeTOKYO BOEKI MEDISYS INC.CEM2019-09-30
00894472000244OPTI CCA E CassetteOPTI MEDICAL SYSTEMS, INC.CEM2019-08-07
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00386100003203Wash Solution MEDICA CORPORATIONCEM2018-12-04
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