Accessories starter kit for ABL800 FLEX

Basic Information

• Brand Name: Accessories starter kit for ABL800 FLEX
• Primary DI: 05700699058348
• Version / Model: 905-834
• Catalog Number: 905-834
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 373c40ec-d82d-4b09-a2a2-c39ddb4fae47
• Distribution End Date: 2023-05-02

Device Description

Accessories starter kit for ABL800 FLEX

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
CIG	DIAZO COLORIMETRY, BILIRUBIN	Clinical Chemistry	862.1110	2
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
KQI	ASSAY, FETAL HEMOGLOBIN	Hematology	864.7455	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37178	Transcutaneous blood gas monitor sensor	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699058348	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius