FDA UDI
In Commercial Distribution
🇺🇸 United States
Multiscreen-HV
DI: 04053252505928
·
Model: MAHVN4550
·
MERCK MILLIPORE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Multiscreen-HV
- Primary DI
- 04053252505928
- Version / Model
- MAHVN4550
- Company Name
- MERCK MILLIPORE LIMITED
- Labeler DUNS
- 896873994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-13
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 2fdf5fb3-cd5c-4205-bf3b-b6889122ed37
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 |
|---|---|---|---|---|
| JRL | Unit, Filter, Membrane | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65389 | Fluid specimen concentration filter IVD | A screening receptacle intended to concentrate a fluid clinical specimen [e.g., serum, urine, cerebrospinal fluid (CSF)] by filtration prior to in vitro diagnostic investigation. It is in the form of a container (e.g., tube, multi-well reservoir) with a semi-permeable filtering membrane, whereby specimen suspension particles [e.g., tissue culture extracts, cells, antigens, antibodies, proteins, hormones, DNA, RNA, column eluates, salts] are retained in a recoverable sub-volume of the specimen after filtration (e.g., by centrifugation, or absorption). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053252505928 | GS1 |