FDA UDI
In Commercial Distribution
🇺🇸 United States
HPH-1000TS HEMOCONCENTRATOR
DI: 08056992333604
·
Model: 04
·
MEDICA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HPH-1000TS HEMOCONCENTRATOR
- Primary DI
- 08056992333604
- Version / Model
- 04
- Catalog Number
- 93024-124
- Company Name
- MEDICA SPA
- Labeler DUNS
- 435402151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-01
- Public Version
- 1
- Public Version Date
- 2026-04-09
- Public Version Status
- New
- Public Device Record Key
- 518425ea-3687-47ff-a7da-0800cc5dc0a3
Device Description
HPH-1000TS HEMOCONCENTRATOR
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44602 | Haemoconcentrator | A sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056992333604 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923139 | 000 |