DIASAFE®plusUS F00007039
GUDID 10840861102133
Fresenius Medical Care Renal Therapies Group, LLC
Haemodialysis system dialysate pyrogen filter| Primary Device ID | 10840861102133 |
| NIH Device Record Key | a7892663-0928-4743-9b14-0f770dc6119f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIASAFE®plusUS |
| Version Model Number | F00007039 |
| Catalog Number | F00007039 |
| Company DUNS | 079732391 |
| Company Name | Fresenius Medical Care Renal Therapies Group, LLC |
| 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 | true |
| 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
Device Dimensions
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 Square meter |
| Area/Surface Area | 2.1 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 |
| 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 |
| 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 |
| 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 | 00840861102136 [Primary] |
| GS1 | 10840861102133 [Package] Contains: 00840861102136 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231534
FDA Product Code
| FIP | Subsystem, Water Purification |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-04 |
| Device Publish Date | 2024-02-23 |
Devices Manufactured by Fresenius Medical Care Renal Therapies Group, LLC
| 10840861102829 - Bicarby | 2024-10-18 Bicarby Dialysate RFP-402 |
| 00840861102839 - Bicarby | 2024-10-18 Bicarby Dialysate RFP-400 |
| 10840861102843 - Bicarby | 2024-10-18 Bicarby Dialysate RFP-407 |
| 10840861102850 - Bicarby | 2024-10-18 Bicarby Dialysate RFP-401 |
| 10840861102768 - PureFlow | 2024-06-07 PureFlow RFP-402 |
| 10840861102775 - PureFlow | 2024-06-07 PureFlow RFP-400 |
| 10840861102782 - PureFlow | 2024-06-07 PureFlow RFP-407 |
| 10840861102799 - PureFlow | 2024-06-07 PureFlow RFP-401 |
Trademark Results [DIASAFE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIASAFE 75127470 2221928 Live/Registered |
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH 1996-07-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.