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VitalScan HRV

FDA UDI

Class II (US FDA UDI)

by Medeia Inc

Identity

Trade Name
VitalScan HRV FDA UDI
Generic Name
Pulse Co-oximeter probe, reusable FDA UDI
Model / Reference
HW6 FDA UDI

Identifiers

Primary DI / UDI-DI
08690020003031 FDA UDI
510(k) Number
K083735 FDA UDI
FDA Product Code
DPS FDA UDI
JOM FDA UDI
GMDN Term
Pulse Co-oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2340 FDA UDI
870.2780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse Co-oximeter probe, reusableElectrocardiograph, professional, single-channel

VitalScan HRV by Medeia Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiograph, professional, single-channel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medeia Inc

Sources (1)

  • FDA UDI 3d71589c-2663-4a22-ac2d-7ee9b805fc16 33 fields · synced Jun 8, 2026