FDA UDI
In Commercial Distribution
🇺🇸 United States
DIASAFE®plusUS
DI: 00840861102136
·
Model: F00007039
·
Fresenius Medical Care Renal Therapies Group, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DIASAFE®plusUS
- Primary DI
- 00840861102136
- Version / Model
- F00007039
- Catalog Number
- F00007039
- Company Name
- Fresenius Medical Care Renal Therapies Group, LLC
- Labeler DUNS
- 079732391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 2
- Public Version Date
- 2025-01-27
- Public Version Status
- Update
- Public Device Record Key
- a7892663-0928-4743-9b14-0f770dc6119f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47739 | Haemodialysis system dialysate pyrogen filter | A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840861102133 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00840861102136 | GS1 |
Customer Contacts
- Phone
- 1-800-323-5188
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 2.1 | Square meter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius