BioTrend®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: BioTrend® FDA UDI
Generic Name: Extracorporeal blood gas/pH monitor FDA UDI
Device Name: INS R95198-004 BIOTREND UNIV 8LDOM FDA UDI
Model / Reference: R95198-04 FDA UDI
Description: INS R95198-004 BIOTREND UNIV 8LDOM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000216269 FDA UDI
510(k) Number: K093650 FDA UDI
FDA Product Code: DTY FDA UDI
GMDN Term: Extracorporeal blood gas/pH monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4410 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Extracorporeal blood gas/pH monitor

BioTrend® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K093650 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

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI ec72f358-bcbe-4bac-bf18-391e66579d26 36 fields · synced May 30, 2026