DIASAFE®plusUS F00007039
GUDID 10840861102133
Fresenius Medical Care Renal Therapies Group, LLC
Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter 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
| 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 |
| 10840861102362 - 5008X HDF Hemodialysis Blood Tubing Set | 2024-04-16 |
| 10840861102379 - 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber | 2024-04-16 |
| 10840861102386 - 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw | 2024-04-16 |
| 10840861102461 - 5008X Fluid Sampling Accessory | 2024-04-16 |
Trademark Results [DIASAFE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIASAFE 75127470 2221928 Live/Registered |
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH 1996-07-01 |
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