FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812
DI: 00817302020526
·
Model: 88812
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812
- Primary DI
- 00817302020526
- Version / Model
- 88812
- Catalog Number
- 88812
- 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
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- 13c8016b-d086-4ad2-b059-08c5ea930542
Device Description
CO2 (Carbon Dioxide) Acid w/ cal - Modular & CX3 Reagent 1 x 2000 mL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JFL | PH RATE MEASUREMENT, CARBON-DIOXIDE | Clinical Chemistry | 862.1160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302020526 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Kit contains 1 R1 and 1 package insert | ||
| Total Volume | 2000 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored at 8-30° C until expiration date
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 30 Degrees Celsius