HEMOSPHERE FORESIGHT MODULE

Basic Information

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Primary DI: 00690103208573
• Version / Model: HEMFSM10
• Catalog Number: HEMFSM10
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 2
• Public Version Date: 2022-08-10
• Public Version Status: Update
• Public Device Record Key: 526b217f-6e33-4415-a890-9bfdd557e86c

Device Description

HEMOSPHERE FORESIGHT MODULE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	870.1230	2
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	870.2210	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	870.5600	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46615	Tissue saturation oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.	No	Active
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103208573	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180003	000
K213682	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Monitor: Height: 297 mm, Width: 315 mm, Depth: 141 mm, Weight: 4.5 kg (10 lbs)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in cool, dry place