FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. Carbon Dioxide
DI: 00811727014979
·
Model: OC702-180
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc. Carbon Dioxide
- Primary DI
- 00811727014979
- Version / Model
- OC702-180
- Catalog Number
- OC702-180
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 74e18673-d2de-43cf-921e-e6879d106b8e
Device Description
Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only. 4 x 45ml
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 |
|---|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | Clinical Chemistry | 862.1160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60768 | Carbon dioxide (CO2) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carbon dioxide (CO2) in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727014979 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070251 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius