V-STATS™ Installation CD

FDA UDI

Class II (US FDA UDI)

by Sentec, Inc.

Identity

Trade Name: V-STATS™ Installation CD FDA UDI
Generic Name: Transcutaneous blood gas monitoring system FDA UDI
Device Name: PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™. FDA UDI
Model / Reference: V-STATS_CD FDA UDI
Description: PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™. FDA UDI

Identifiers

Primary DI / UDI-DI: 07640121880773 FDA UDI
510(k) Number: K041548 FDA UDI
K071672 FDA UDI
K101690 FDA UDI
K151329 FDA UDI
FDA Product Code: DPZ FDA UDI
DQA FDA UDI
KLK FDA UDI
LKD FDA UDI
LPP FDA UDI
GMDN Term: Transcutaneous blood gas monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2710 FDA UDI
870.2700 FDA UDI
868.2500 FDA UDI
868.2480 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulse Co-oximeter probe, reusable Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitoring system

V-STATS™ Installation CD by Sentec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K041548 also covers:

K071672 also covers:

K101690 also covers:

K151329 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: Sentec, Inc.

Sources (1)

FDA UDI b93d910a-9f6b-4edf-a6d7-0781dcb1606b 34 fields · synced May 30, 2026