FDA UDI
In Commercial Distribution
🇺🇸 United States
HEMODROP BLOOD DISPENSER
DI: 00853778007128
·
Model: BMP-HEMODROP
·
Biomedical Polymers, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HEMODROP BLOOD DISPENSER
- Primary DI
- 00853778007128
- Version / Model
- BMP-HEMODROP
- Company Name
- Biomedical Polymers, Inc.
- Labeler DUNS
- 037687837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-22
- Public Version
- 1
- Public Version Date
- 2023-08-30
- Public Version Status
- New
- Public Device Record Key
- 28f900b4-cd1e-4d1a-a2e8-10b975f63067
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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62550 | Blood smearing manual instrument IVD | A manual laboratory instrument intended to be used to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. The device operates with technician involvement in most procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853778007125 | GS1 | Inner Case | 1000 | In Commercial Distribution | |
| Primary | 00853778007128 | GS1 | ||||
| Package | 20853778007122 | GS1 | Case | 27 | In Commercial Distribution |