FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemocor HPH
DI: 00677964011184
·
Model: HPH 700TS
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hemocor HPH
- Primary DI
- 00677964011184
- Version / Model
- HPH 700TS
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2022-04-27
- Public Version Status
- Update
- Public Device Record Key
- c87863d9-3552-470d-a0d5-e29f8c114fdc
Device Description
High Performance 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
- No
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 |
|---|---|---|---|---|
| 47072 | Hollow-fibre haemodialysis dialyser, single-use | A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30677964011185 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00677964011184 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983085 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius