ABL800 FLEX

Basic Information

• Brand Name: ABL800 FLEX
• Primary DI: 05700693938011
• Version / Model: 393-801
• Catalog Number: 393-801
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: cb64116c-4b51-469e-b0d9-94cb756723bd

Device Description

ABL800 FLEX with crea

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: No
• 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
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
KQI	ASSAY, FETAL HEMOGLOBIN	Hematology	864.7455	2
CIG	DIAZO COLORIMETRY, BILIRUBIN	Clinical Chemistry	862.1110	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700693938011	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Type: Handling Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 60 – 107 KiloPascal