FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Cytology Funnel w/ Brown Card
DI: 00853778007142
·
Model: BMP-CYTO-S50BP
·
Biomedical Polymers, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single Cytology Funnel w/ Brown Card
- Primary DI
- 00853778007142
- Version / Model
- BMP-CYTO-S50BP
- Company Name
- Biomedical Polymers, Inc.
- Labeler DUNS
- 037687837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-21
- Public Version
- 1
- Public Version Date
- 2023-08-29
- Public Version Status
- New
- Public Device Record Key
- e745cc52-f049-484c-bdbd-3d4012bfba18
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KET | Filters, Cell Collection, Tissue Processing | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63732 | Cytological centrifuge funnel IVD | A small, tapered receptacle designed to be fitted into a cytological centrifuge/sample concentrator, and intended to contain and help concentrate clinical specimen suspension cells into thin-layer preparations by depositing them directly onto a microscope slide during centrifugation for subsequent examination. It is in the form of a conical-shaped plastic receptacle; some types have a slot for inserting a microscope slide. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853778007149 | GS1 | Inner Pack | 50 | In Commercial Distribution | |
| Primary | 00853778007142 | GS1 | ||||
| Package | 20853778007146 | GS1 | Case | 10 | In Commercial Distribution |