DEVICE: ABL90 FLEX, Clot catcher (05700699060266)

Device Identifier (DI) Information

ABL90 FLEX, Clot catcher
906-026
In Commercial Distribution
906-026
Radiometer Medical ApS
05700699060266
GS1

250
308667539 *Terms of Use
ABL90 FLEX, Clot catcher, box of 250 pcs.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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.
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c9bd93da-c1bc-47c1-bc08-d226110321f0
March 29, 2018
2
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 55700699060261 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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