FDA.reportPublic FDA data

MR Patient Care Temperature Sensor Jacket

Primary DI
10884838111407
Brand
MR Patient Care Temperature Sensor Jacket
Company
Philips Medizin Systeme Böblingen GmbH
Model
Temperature Sensor Jacket
Catalog number
989803178181
Device description
Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection
Published
2025-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884838111407PrimaryGS10
00884838111400Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088483811140710884838111407
00884838111400008848381114008848381114000884838111400

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
314101143
Device count
10
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26
00884838119130Telemetry AccessoriesECG Trunk Cable AAMI/IEC9898031722212026-05-26
00884838119147Telemetry AccessoriesTelemetry Adapter 6L+SpO29898031990712026-05-26
00884838119154Telemetry AccessoriesTelemetry Adapter SpO2-only9898031990812026-05-26
00884838119161Telemetry AccessoriesTelemetry Adapter 5L+SpO29898031990912026-05-26
00884838119178Telemetry AccessoriesTelemetry Adapter 3L+SpO29898031991012026-05-26
20884838119233Telemetry AccessoriesECG 5 lead Grabber, AAMI, SPU, Tele9898031720312026-05-26
20884838119240Telemetry AccessoriesECG 5 lead Grabber, IEC, SPU, Tele9898031721312026-05-26
00884838117396patient lead wire12L Leadset, Grabber, AAMI9898031801212026-05-21
00884838117402patient lead wire12L Leadset, Grabber, IEC9898031801312026-05-21
00884838117419patient lead wire12L Leadset, Snaps, AAMI9898031801412026-05-21
00884838117426patient lead wire12L Leadset, Snaps, IEC9898031801512026-05-21
20884838119769Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2,SPU,Tele9898031720512026-05-19
20884838119776Telemetry AccessoriesECG 5 Lead Grabber IEC + SpO2, SPU, Tele9898031721512026-05-19
00884838107816Measurement Rack 6000Measurement Rack 60008673172026-05-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08719689142131QMAPP Fysicon B.V.MWI2026-05-19
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08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MWI2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.MWI2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.MWI2026-03-18
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10884838115092MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-03-09
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14250892908509JaegerJaeger Medical GmbHMWI2025-11-24
14250892908936JaegerJaeger Medical GmbHMWI2025-11-24
34250892909012JaegerJaeger Medical GmbHMWI2025-11-24
34250892909029JaegerJaeger Medical GmbHMWI2025-11-24
34250892908367JaegerJaeger Medical GmbHMWI2025-10-31
34250892908541JaegerJaeger Medical GmbHMWI2025-10-31
34250892908589JaegerJaeger Medical GmbHMWI2025-10-31
10884838117874MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120805MR Patient Care Infant NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120812MR Patient Care Pediatric NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120829MR Patient Care Small Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120836MR Patient Care Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120843MR Patient Care Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120867MR Patient Care Large Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120874MR Patient Care Large Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22