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Hemosphere

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
HEMOSPHERE FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Mindray OEM Pressure Smart Cable FDA UDI
Model / Reference
PSCOEM100MR FDA UDI
Description
Mindray OEM Pressure Smart Cable FDA UDI

Identifiers

Catalog Number
PSCOEM100MR FDA UDI
Primary DI / UDI-DI
00690103216998 FDA UDI
510(k) Number
K191089 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: General-purpose multi-parameter bedside monitor

Hemosphere 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 cedbf7ec-aa3d-4cef-9209-722127005ddc 37 fields · synced Jun 8, 2026