FDA.reportPublic FDA data

Electrode for ABL analyzers

Primary DI
05700699456052
Brand
Electrode for ABL analyzers
Company
Radiometer Medical ApS
Model
945-605
Catalog number
945-605
Device description
E5250-0 TC pO2 electrode
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPPMonitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699456052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699456052057006994560525700699456052

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitor sensorA device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699565259PICO70956-525956-5252016-09-01
05700699565334PICO70956-533956-5332016-09-01
05700699565471PICO70956-547956-5472016-09-01
05700699566089safePICO70956-608956-6082016-09-01
05700699566096safePICO70956-609956-6092016-09-01
05700699566126safePICO70956-612956-6122016-09-01
05700699566133safePICO70956-613956-6132016-09-01
05700699566140safePICO70956-614956-6142016-09-01
05700699566157safePICO70956-615956-6152016-09-01
05700699566164safePICO70956-616956-6162016-09-01
05700699566232safePICO956-623956-6232016-09-01
05700699566249safePICO70956-624956-6242016-09-01
05700699056894TC contact liquid905-689905-6892016-09-01
05700693930978ABL90 FLEX393-097393-0972026-07-09
05700693930985ABL90 FLEX PLUS393-098393-0982026-07-09
05700699446572SP90944-657944-6572026-07-09
05700699447579SP90944-757944-7572026-07-09
05700699461056SC90946-105946-1052026-07-09
05700699461087SC90946-108946-1082026-07-09
05700699461094SC90946-109946-1092026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSLPP2025-04-23
07640121880988103149 Calibration GasSenTec AGLPP2024-07-05
07640121880995103164 tCOM+SenTec AGLPP2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGLPP2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGLPP2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGLPP2024-07-05
07640121881039Non-Adhesive WrapSenTec AGLPP2023-07-21
07332834000790PF 6840-1 TC Remote Panel 1 ChannelPerimed ABLPP2023-02-01
07332834000806PF 6840-2 TC Remote Panel 2 ChannelsPerimed ABLPP2023-02-01
07332834000820PF 6840-4 TC Remote Panel 4 ChannelsPerimed ABLPP2023-02-01
07640121880964Patient Application Kit for mature intact skinSenTec AGLPP2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGLPP2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGLPP2021-09-26
07640121880889SDM Water Protection CoverSenTec AGLPP2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGLPP2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGLPP2021-02-28
07640121880810Ear Clip easySenTec AGLPP2020-03-31
17640121880817Ear Clip easySenTec AGLPP2020-03-31
07640121880858Contact Gel 2mlSenTec AGLPP2019-03-08
17640121880862Contact GelSenTec AGLPP2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGLPP2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGLPP2019-01-29
17640121880800Multi-Site Attachment Ring for fragile/sensitive sSenTec AGLPP2019-01-29
07640121880315PSG-XSenTec AGLPP2018-11-12
07640121880612PSG Cable ASenTec AGLPP2018-11-12
07640121880629PSG Cable BSenTec AGLPP2018-11-12
07640121880636PSG Cable CSenTec AGLPP2018-11-12
07640121880643PSG Cable DSenTec AGLPP2018-11-12
07640121880650PSG Cable ESenTec AGLPP2018-11-12
07640121880667PSG Cable FSenTec AGLPP2018-11-12