FDA.reportPublic FDA data

Essential MRI Patient Monitor (Model 865353)

Primary DI
00884838012585
Brand
Essential MRI Patient Monitor (Model 865353)
Company
Philips Ds North America LLC
Model
Essential MRI Patient Monitor
Catalog number
865353
Device description
Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI environment. Key Features include: Communicates wirelessly with Invivo. Expression or Precess 2nd-Gen wSpO2 Modules for seamless patient transitions, Touch Screen Display Unrestricted MRI Gauss Rating, Lightweight portable Alarm light All parameters support Adult, Pediatric, infant and Neonatal applications,8-Hour Smart Battery Technology, Environmentally friendly Green, Flexible mounting options. One (1) year limited warranty and factory service for hardware
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103700000ESSENTIAL MRI PATIENT MONITORInvivo Corporation2011-03-15DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838012585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838012585008848380125858848380125850884838012585

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
013649151
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838072657Invivo989603208432016-09-23
00884838072664Invivo989603203332016-09-23
00884838072756Invivo989603203272016-09-23
00884838072763Invivo989603203282016-09-23
00884838072770Invivo989603208422016-09-23
00884838072787Invivo989603204212016-09-23
00884838072794Invivo989603203302016-09-23
00884838072800Invivo989603203312016-09-23
00884838072817Invivo989603203322016-09-23
00884838100114Invivo4535-302-233312020-04-17
00884838066991Invivo7840112016-09-23
00884838072558Invivo989603205282016-09-23
00884838072565Invivo989603203012016-09-23
00884838072572Invivo989603203022016-09-23
00884838073456Invivo989603208782016-09-23
00884838073463Invivo989603208792016-09-23
00884838081543Invivo7840122016-09-23
00884838082885Invivo989603210042017-07-28
00884838083592Invivo7840012016-09-23
00884838098459PhilipsdS FLEX-S 1.5T4598017299712021-06-11

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