FDA UDI In Commercial Distribution 🇺🇸 United States

CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313

DI: 00817302022025 · Model: BL313 · CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313
Primary DI
00817302022025
Version / Model
BL313
Catalog Number
BL313
Company Name
CAROLINA LIQUID CHEMISTRIES CORPORATION
Labeler DUNS
962385787
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
3
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
95dc399c-0543-4ab8-a742-eb10f153657d

Device Description

CO2 (Carbon Dioxide) w/ cal 3 x 140 tests

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
KHS ENZYMATIC, CARBON-DIOXIDE

GMDN Terms

Code Name
60768 Carbon dioxide (CO2) IVD, kit, spectrophotometry

Identifiers

Type ID
Primary 00817302022025

Customer Contacts

Device Sizes

Type Value Unit Text
Total Volume 10 Milliliter
Total Volume 40 Milliliter
Device Size Text, specify Kit contains 3 R1, 1 calibrator, 1 reagent package insert and 1 calibrator package insert

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius
Type
Special Storage Condition, Specify
Special Conditions
Reagent is stable when stored at 2-8° C until expiration date