AccessGUDID - DEVICE: Clot catcher (05700699060204)

GUDID

Device Identifier (DI) Information

Brand Name: Clot catcher
Version or Model: 906-020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 906-020
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699060204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: Clot catcher, box of 250 pcs. for ABL7XX

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, stationary, automated	A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (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)]. The device operates with minimal technician involvement and complete automation of all procedural steps.

GMDN Preferred Term Name

GMDN Definition

Metabolic profile clinical chemistry analyser IVD, stationary, automated

A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (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)]. The device operates with minimal technician involvement and complete 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
CGA	GLUCOSE OXIDASE, GLUCOSE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
KHP	ACID, LACTIC, ENZYMATIC METHOD
CIG	DIAZO COLORIMETRY, BILIRUBIN
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

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: bca4988a-32e3-405b-b90a-c068f2518ae9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016