DIASAFE®plusUS

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Renal Therapies Group, LLC

Identity

Trade Name: DIASAFE®plusUS FDA UDI
Generic Name: Haemodialysis system dialysate pyrogen filter FDA UDI
Model / Reference: F00007039 FDA UDI

Identifiers

Catalog Number: F00007039 FDA UDI
Primary DI / UDI-DI: 00840861102136 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Haemodialysis system dialysate pyrogen filter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5665 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Dimensions & Sizes

Size: Area/Surface Area — 2.1 Square meter FDA UDI

Category: Haemodialysis system dialysate pyrogen filter

DIASAFE®plusUS by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

FDA UDI a7892663-0928-4743-9b14-0f770dc6119f 36 fields · synced May 29, 2026