FDA UDI
In Commercial Distribution
🇺🇸 United States
RNA Medical
DI: 10851290002550
·
Model: CVC 123
·
Rna Medical Division
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RNA Medical
- Primary DI
- 10851290002550
- Version / Model
- CVC 123
- Catalog Number
- CVC 123
- Company Name
- Rna Medical Division
- Labeler DUNS
- 101187037
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-11
- Public Version
- 1
- Public Version Date
- 2020-08-19
- Public Version Status
- New
- Public Device Record Key
- ad9dbc8c-1a4e-46f0-99db-cb90138cbc71
Device Description
Carton for CVC 123
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42722 | Flow cytometer calibration/verification solution IVD | A solution containing beads or particles with known optical and physical characteristics (e.g., antibodies conjugated with fluorescent dyes, specified size or other label) intended to be used to verify and/or optimize the performance of a flow cytometer or similar single/multichannel instrument. Verification/optimization functions may include optical density (absorbance), fluorescent or luminescent accuracy and compensation, linearity, repeatability, sensitivity, limit of detection and/or light scatter readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. Solutions are typically single-use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851290002550 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943754 | 000 |