Hemoflow™
GUDID 10840861100047
F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL
Fresenius Medical Care Holdings, Inc.
Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable Hollow-fibre haemodialysis dialyser, reusable| Primary Device ID | 10840861100047 |
| NIH Device Record Key | 9a417d6a-a81c-4517-a040-ab784a5c0f54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemoflow™ |
| Version Model Number | 0500164A |
| Company DUNS | 958291411 |
| Company Name | Fresenius Medical Care Holdings, 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx | |
| Phone | +1(800)323-5188 |
| xx@xx.xx |
Device Dimensions
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
| Area/Surface Area | 1.8 Square meter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861100040 [Primary] |
| GS1 | 10840861100047 [Package] Contains: 00840861100040 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K870725
FDA Product Code
| FJI | DIALYZER, CAPILLARY, HOLLOW FIBER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [Hemoflow™]
| 10840861100023 | F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 42 mL |
| 10840861100016 | F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.4 m2 / ETO / Low Volume / Single Use / 24 mL |
| 10840861100061 | F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL |
| 10840861100054 | F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL |
| 10840861100047 | F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL |
| 10840861100030 | F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL |
Trademark Results [Hemoflow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOFLOW 90578597 not registered Live/Pending |
Fresenius Medical Care Holdings, Inc. 2021-03-15 |
 HEMOFLOW 86855725 5012778 Live/Registered |
INTERACTIVE FLOW STUDIES CORPORATION 2015-12-21 |
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