RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
RAPIDPOINT®340/350 pH Electrode - 10375796
Device Description
A noninvasive electrical conducting device intended to be used to measure the acid-base status of a blood specimen by determining its hydrogen ion concentration. This is a single-use device.
Environmental Conditions
- Close container tightly before air shipment
- 25.00
- 5.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GKF
Device Name: Instrument, Hematocrit, Automated
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.5600
Third Party Flag: N
Medical Specialty: HE
Code: CEM
Device Name: Electrode, Ion Specific, Potassium
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1600
Third Party Flag: Y
Medical Specialty: CH
Code: JFP
Device Name: Electrode, Ion Specific, Calcium
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1145
Third Party Flag: Y
Medical Specialty: CH
Code: CHL
Device Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1120
Third Party Flag: Y
Medical Specialty: CH
Code: JGS
Device Name: Electrode, Ion Specific, Sodium
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1665
Third Party Flag: Y
Medical Specialty: CH
Device Identifiers
Device Id: 00630414566245
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
