Hemocor HPH
GUDID 30677964011116
High Performance Hemoconcentrator
MEDIVATORS INC.
Hollow-fibre haemodialysis dialyser, single-use| Primary Device ID | 30677964011116 |
| NIH Device Record Key | 4e778429-54b0-4e29-a58d-757ea2c9172b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemocor HPH |
| Version Model Number | HPH Mini |
| Company DUNS | 068199363 |
| Company Name | MEDIVATORS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com | |
| Phone | +1(800)444-4729 |
| custserv@MEDIVATORS.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00677964011115 [Primary] |
| GS1 | 30677964011116 [Package] Contains: 00677964011115 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980859
FDA Product Code
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
On-Brand Devices [Hemocor HPH]
| 30677964011253 | High Performance Hemoconcentrator |
| 00677964011245 | High Performance Hemoconcentrator |
| 30677964011239 | High Performance Hemoconcentrator |
| 30677964011222 | High Performance Hemoconcentrator |
| 00677964011214 | High Performance Hemoconcentrator |
| 30677964011208 | High Performance Hemoconcentrator |
| 30677964011185 | High Performance Hemoconcentrator |
| 30677964011178 | High Performance Hemoconcentrator |
| 30677964011116 | High Performance Hemoconcentrator |
| 30677964000868 | High Performance Hemoconcentrator |
Trademark Results [Hemocor HPH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOCOR HPH 74299209 1820542 Live/Registered |
MEDIVATORS INC. 1992-07-28 |
HEMOCOR HPH 74299209 1820542 Live/Registered |
EVOQUA WATER TECHNOLOGIES LTD 1992-07-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.