ViraGuard Viral Blocking Patient Transducer Protector

FDA UDI

Class II (US FDA UDI)

by Medisystems Corp.

Identity

Trade Name: ViraGuard Viral Blocking Patient Transducer Protector FDA UDI
Generic Name: Haemodialysis system transducer protector FDA UDI
Model / Reference: M8-2006 FDA UDI

Identifiers

Primary DI / UDI-DI: M535M820062 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Haemodialysis system transducer protector

ViraGuard Viral Blocking Patient Transducer Protector by Medisystems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system transducer protector.

NIPRO TP-SURE — NIPRO MEDICAL CORPORATION · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · 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
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II

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: Medisystems Corp.

Sources (1)

FDA UDI 5a30417d-51ff-45f5-a797-7141105453ea 34 fields · synced Jun 8, 2026