AccessGUDID - DEVICE: HemoSphere Tissue Oximetry Module (00690103200355)

GUDID

Device Identifier (DI) Information

Brand Name: HemoSphere Tissue Oximetry Module
Version or Model: HEMTOM10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HEMTOM10
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103200355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: HemoSphere Tissue Oximetry Module

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUD	Oximeter, Tissue Saturation
QAQ	Adjunctive Predictive Cardiovascular Indicator
DQE	Catheter, Oximeter, Fiber-Optic
DQK	Computer, Diagnostic, Programmable
DXN	System, Measurement, Blood-Pressure, Non-Invasive
DSB	Plethysmograph, Impedance
QMS	Adjunctive Open Loop Fluid Therapy Recommender
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b924559c-1305-4476-a0d3-161f7e5e70be
Public Version Date: July 24, 2023
Public Version Number: 8
DI Record Publish Date: September 12, 2019