FDA UDI
In Commercial Distribution
🇺🇸 United States
.02M Calcium Chloride
DI: 00817869020007
·
Model: CR-109
·
ANALYTICAL CONTROL SYSTEMS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- .02M Calcium Chloride
- Primary DI
- 00817869020007
- Version / Model
- CR-109
- Catalog Number
- CR-109
- Company Name
- ANALYTICAL CONTROL SYSTEMS INC
- Labeler DUNS
- 038232682
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-31
- Public Version
- 1
- Public Version Date
- 2019-03-04
- Public Version Status
- New
- Public Device Record Key
- c5e24d84-b395-495f-9bf6-0673278c3824
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30593 | Calcium chloride coagulation reagent IVD | A calcium chloride solution intended to be used alone or in combination with other IVDs in the performance of coagulation tests or other laboratory investigations of clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817869020007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K902458 | 000 |