AccessGUDID - DEVICE: Cleaning Solution with additive S8375 REF 944-126 (05700699441263)

GUDID

Device Identifier (DI) Information

Brand Name: Cleaning Solution with additive S8375 REF 944-126
Version or Model: 944-126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 944-126
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699441263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: S8375 Cleaning Solution 175mL for ABL8XX

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHP	ACID, LACTIC, ENZYMATIC METHOD
CGA	GLUCOSE OXIDASE, GLUCOSE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CIG	DIAZO COLORIMETRY, BILIRUBIN
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph
GHS	ASSAY, CARBOXYHEMOGLOBIN
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KQI	ASSAY, FETAL HEMOGLOBIN
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

[?]

Storage and Handling
Special Storage Condition, Specify: Single use
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f98224c8-4caa-40a1-938e-910427e0f72a
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 21, 2018