FDA UDI
In Commercial Distribution
🇺🇸 United States
Calcium Chloride
DI: G0561009890
·
Model: 100989
·
Bio/Data Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Calcium Chloride
- Primary DI
- G0561009890
- Version / Model
- 100989
- Catalog Number
- 1009989
- Company Name
- Bio/Data Corporation
- Labeler DUNS
- 051392959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-30
- Public Version
- 1
- Public Version Date
- 2023-09-07
- Public Version Status
- New
- Public Device Record Key
- a6ec0a2f-e15e-4250-95ba-c4c2bd32c06a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| KQJ | System, Fibrinogen Determination | Hematology | 864.7340 | 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 | G0561009890 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K792563 | 000 |