Identity
- Trade Name
- 5008X FDA UDI
- Generic Name
- Haemodialysis system transducer protector FDA UDI
- Device Name
- 5008X Venous Pressure Replacement Line with Transducer Protector FDA UDI
- Model / Reference
- 04-9310-6 FDA UDI
- Description
- 5008X Venous Pressure Replacement Line with Transducer Protector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102600 FDA UDI
- 510(k) Number
- K243505 FDA UDI
- FDA Product Code
- FJK FDA UDI
- GMDN Term
- Haemodialysis system transducer protector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemodialysis system transducer protector
5008x by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system transducer protector.
- ViraGuard Viral Blocking Patient Transducer Protector — Medisystems Corp. · Class II
- NIPRO TP-SURE — NIPRO MEDICAL CORPORATION · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Millex - FH — MERCK MILLIPORE LIMITED · Class II
- Hydromillex — MERCK MILLIPORE LIMITED · Class II
- NovaLine — Bain Medical Equipment (Guangzhou) Co., Ltd. · Class II
- Fresenius — Fresenius Medical Care Holdings, Inc. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Cleared under the same submission
K243505 also covers:
- 5008X — Fresenius Medical Care
- 5008X — Fresenius Medical Care
- 5008X — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Support plate — Fresenius Medical Care
- Top Tray — Fresenius Medical Care
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA UDI b37d25b4-f475-4095-af24-8fbd4c460d82 36 fields · synced May 29, 2026