AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812 (00817302020526)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812
Version or Model: 88812
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88812
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CO2 (Carbon Dioxide) Acid w/ cal - Modular & CX3 Reagent 1 x 2000 mL

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
60773	Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of bicarbonate (HCO3-) ions, [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen, using an ion-selective electrode (ISE) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE

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: Reagent is stable when stored at 8-30° C until expiration date
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 1 R1 and 1 package insert
Total Volume: 2000 Milliliter

Device Record Status

Public Device Record Key: 13c8016b-d086-4ad2-b059-08c5ea930542
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016