FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemaprep
DI: 00860010522301
·
Model: 756300
·
J P Gilbert Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hemaprep
- Primary DI
- 00860010522301
- Version / Model
- 756300
- Catalog Number
- 756300
- Company Name
- J P Gilbert Company Inc
- Labeler DUNS
- 949182117
- 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
- 25ad61db-f412-459f-bda9-1ff043c8b2f1
Device Description
Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GKJ | Spinner, Slide, Automated | Hematology | 864.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15110 | Microscope slide maker IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010522301 | GS1 |
Customer Contacts
- Phone
- 610 367-7457
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 5.4 | Inch | |
| Depth | 6.3 | Inch | |
| Width | 3.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- none
- Type
- Special Storage Condition, Specify
- Special Conditions
- no special storage condition for shipment or storage