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HemoSphere Vita

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
HemoSphere Vita FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
PRESSURE CONTROLLER KIT FDA UDI
Model / Reference
HEMPC2K FDA UDI
Description
PRESSURE CONTROLLER KIT FDA UDI

Identifiers

Catalog Number
HEMPC2K FDA UDI
Primary DI / UDI-DI
00690103217124 FDA UDI
FDA Product Code
DXN FDA UDI
DSB FDA UDI
QMS FDA UDI
DQE FDA UDI
DQK FDA UDI
MUD FDA UDI
FLL FDA UDI
QAQ FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
870.2770 FDA UDI
870.5600 FDA UDI
870.1230 FDA UDI
870.1425 FDA UDI
870.2700 FDA UDI
880.2910 FDA UDI
870.2210 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: General-purpose multi-parameter bedside monitor

HemoSphere Vita by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 51696ac8-28bd-41bf-b231-810ea6a5a21d 36 fields · synced Jun 8, 2026