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Hemo-Nate

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
HEMO-NATE FDA UDI
Generic Name
Blood transfusion filter FDA UDI
Device Name
FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter FDA UDI
Model / Reference
Filter Set FDA UDI
Description
FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter FDA UDI

Identifiers

Catalog Number
4020007 FDA UDI
Primary DI / UDI-DI
H67140200070 FDA UDI
510(k) Number
K781815 FDA UDI
FDA Product Code
FPB FDA UDI
GMDN Term
Blood transfusion filter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

Dimensions & Sizes

Size
Pore Size — 18 Micrometer FDA UDI

Category: Blood transfusion filter

Hemo-Nate by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood transfusion filter.

Cleared under the same submission

K781815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI 35244ce7-5985-4c23-ae40-dfdf99a8a973 37 fields · synced Jun 9, 2026