FDA UDI
In Commercial Distribution
🇺🇸 United States
Minicon CS15
DI: 04054839155017
·
Model: 9051
·
MERCK MILLIPORE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Minicon CS15
- Primary DI
- 04054839155017
- Version / Model
- 9051
- Company Name
- MERCK MILLIPORE LIMITED
- Labeler DUNS
- 896873994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2022-05-11
- Public Version Status
- Update
- Public Device Record Key
- ed9528b3-3c4b-4504-a1fe-4ffd0f20f6dc
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47062 | Laboratory dialyser | A device designed to perform dialysis in laboratory samples, a procedure that combines the separation of molecules with different characteristics through a semi-permeable membrane (diffusion) and the simultaneous movement of fluid through the membrane under imposed pressure gradients (ultrafiltration). The device typically consists of a container for the solution to be dialysed (e.g., serum, urine), a container for the solution that performs the dialysis (i.e., dialysate), and a semi-permeable membrane separating them. It is used in clinical laboratories for several procedures such as cerebrospinal fluid concentration, and electrophoresis and chromatography sample preparation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04054839155017 | GS1 | ||||
| Unit of Use | 04054839155024 | GS1 |