Electrode for ABL analyzers

FDA UDI

Class I (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name: Electrode for ABL analyzers FDA UDI
Generic Name: Lactate electrode IVD FDA UDI
Device Name: E7077 Lactate electrode for ABL7XX/8XX FDA UDI
Model / Reference: 945-619 FDA UDI
Description: E7077 Lactate electrode for ABL7XX/8XX FDA UDI

Identifiers

Catalog Number: 945-619 FDA UDI
Primary DI / UDI-DI: 05700699456199 FDA UDI
FDA Product Code: KHP FDA UDI
KQI FDA UDI
CGL FDA UDI
JGS FDA UDI
GHS FDA UDI
CGA FDA UDI
CIG FDA UDI
CHL FDA UDI
CEM FDA UDI
MQM FDA UDI
JFP FDA UDI
CGZ FDA UDI
GMDN Term: Lactate electrode IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1450 FDA UDI
864.7455 FDA UDI
862.1225 FDA UDI
862.1665 FDA UDI
864.7425 FDA UDI
862.1345 FDA UDI
862.1110 FDA UDI
862.1120 FDA UDI
862.1600 FDA UDI
862.1113 FDA UDI
862.1145 FDA UDI
862.1170 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Lactate electrode IVD

Electrode for ABL analyzers by Radiometer Medical ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lactate electrode IVD.

Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
i-STAT — Abbott Point of Care Inc. · Class I
TB4 Glu/Lac Test/Blank Sensor — Siemens Healthcare Diagnostics · Class I
Membrane for E7077 electrode — Radiometer Medical ApS · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Radiometer Medical ApS

Sources (1)

FDA UDI 49c3d934-9a46-46d6-b432-46d6bfccc343 35 fields · synced Jun 8, 2026