DEVICE: ABL90 FLEX, Clot catcher (05700699060266)
Device Identifier (DI) Information
ABL90 FLEX, Clot catcher
906-026
In Commercial Distribution
906-026
Radiometer Medical ApS
906-026
In Commercial Distribution
906-026
Radiometer Medical ApS
ABL90 FLEX, Clot catcher, box of 250 pcs.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
66079 | Analyser blood clot protection filter IVD |
A screening device intended to be placed in a blood specimen receptacle (e.g., capillary blood collection tube) prior to loading it into an in vitro diagnostic analyser (e.g., blood gas analyser) to trap blood clots and prevent them from entering the analyser. This is a single-use device.
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Active | false |
FDA Product Code
[?]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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c9bd93da-c1bc-47c1-bc08-d226110321f0
August 22, 2023
5
September 01, 2016
August 22, 2023
5
September 01, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
55700699060261
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk