FDA UDI
In Commercial Distribution
🇺🇸 United States
CARPEDIEM
DI: 08032979792299
·
Model: IB0595580
·
BELLCO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CARPEDIEM
- Primary DI
- 08032979792299
- Version / Model
- IB0595580
- Company Name
- BELLCO SRL
- Labeler DUNS
- 338685723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-17
- Public Version
- 10
- Public Version Date
- 2025-12-12
- Public Version Status
- Update
- Public Device Record Key
- 5be88ebf-0b95-410c-a828-ba8cb5df328d
Device Description
BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| QIR | Pediatric Hemodialysis System | Gastroenterology, Urology | 876.5861 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61674 | Haemodialysis/haemofiltration system component set | A collection of sterile devices, which includes a dialyser, intended to be integrated within a system for haemodialysis and haemofiltration to treat acute or chronic renal failure by removing toxins and/or replacing electrolytes in blood; it may also be used in the treatment of fluid overload (hypervolemia). In addition to the dialyser the set includes an array of tubing and connectors, and is intended to be connected to the system pump/monitor; it is intended to be used in the home and healthcare settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38032979792290 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 08032979792299 | GS1 |
Customer Contacts
- Phone
- +39053529111
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | syringe volume;10;ML; |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- avoid direct sunlight