Identity
- Trade Name
- Molded Products, Inc. FDA UDI
- Generic Name
- Haemodialysis system transducer protector FDA UDI
- Device Name
- Dialysis Transducer Protector FDA UDI
- Model / Reference
- MPC-85 FDA UDI
- Description
- Dialysis Transducer Protector FDA UDI
Identifiers
- Catalog Number
- MPC-85 FDA UDI
- Primary DI / UDI-DI
- B144MPC852 FDA UDI
- 510(k) Number
- K925978 FDA UDI
- FDA Product Code
- FIB 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
Molded Products, Inc. by Molded Products Inc. — 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
- Millex - FH — MERCK MILLIPORE LIMITED · Class II
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC · 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
- Pall — Pall International SARL · Class II
Cleared under the same submission
K925978 also covers:
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
- Molded Products Inc.
Sources (1)
- FDA UDI 5c7f1693-4727-4ff9-b2cd-f1105e779a32 35 fields · synced May 30, 2026