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© 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.
Active false
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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
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c9bd93da-c1bc-47c1-bc08-d226110321f0
August 22, 2023
5
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

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

[?]
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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