FDA UDI
In Commercial Distribution
🇺🇸 United States
Renaflo II Hemofilter
DI: 00677964000065
·
Model: HF 400
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Renaflo II Hemofilter
- Primary DI
- 00677964000065
- Version / Model
- HF 400
- Catalog Number
- 93024130
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 6
- Public Version Date
- 2023-07-19
- Public Version Status
- Update
- Public Device Record Key
- 6b578ac0-9735-4f24-b35c-a19885027375
Device Description
Renaflo II Hemofilter HF 400
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
- Yes
- 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 |
|---|---|---|---|---|
| 44601 | Haemofilter | A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30677964000066 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 00677964000065 | GS1 |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923312 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius