FDA UDI
In Commercial Distribution
🇺🇸 United States
5008X
DI: 00840861102600
·
Model: 04-9310-6
·
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
- 5008X
- Primary DI
- 00840861102600
- Version / Model
- 04-9310-6
- 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
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- b37d25b4-f475-4095-af24-8fbd4c460d82
Device Description
5008X Venous Pressure Replacement Line with Transducer Protector
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32109 | Haemodialysis system transducer protector | A device designed to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent transfer of by viruses, bacteria, and particulate matter, while preventing the flow of fluids, to the pressure monitor. It may feature tubing and a male Luer lock designed to facilitate replacement of a contaminated transducer protector via a secondary connection on the pressure monitor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840861102607 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 00840861102600 | GS1 |
Customer Contacts
- Phone
- 1 (800) 227-2572
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243505 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Protect from moisture, freezing and excessive heat.