AccessGUDID - DEVICE: ABL90 FLEX, Clot catcher (05700699060266)

GUDID

Device Identifier (DI) Information

Brand Name: ABL90 FLEX, Clot catcher
Version or Model: 906-026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 906-026
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699060266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: ABL90 FLEX, Clot catcher, box of 250 pcs.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Metabolic profile clinical chemistry analyser IVD, portable, automated	A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.

GMDN Preferred Term Name

GMDN Definition

Metabolic profile clinical chemistry analyser IVD, portable, automated

A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.

FDA Product Code

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Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CGA	GLUCOSE OXIDASE, GLUCOSE
GHS	ASSAY, CARBOXYHEMOGLOBIN
KQI	ASSAY, FETAL HEMOGLOBIN
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JJY	Multi-analyte controls, all kinds (assayed)
KHP	ACID, LACTIC, ENZYMATIC METHOD
JGS	ELECTRODE, ION SPECIFIC, SODIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9bd93da-c1bc-47c1-bc08-d226110321f0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016