FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluid Pack
DI: 00811403010486
·
Model: AV-BP5186D
·
Diamond Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fluid Pack
- Primary DI
- 00811403010486
- Version / Model
- AV-BP5186D
- Company Name
- Diamond Diagnostics Inc.
- Labeler DUNS
- 947514303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- a74f0a89-d703-4bf7-9117-c23d33ebd9a7
Device Description
To provide calibration points for the Sodium, Potassium, Chloride, Calcium and Lithium Electrodes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52867 | Multiple electrolyte IVD, calibrator | A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811403010486 | GS1 |