FDA.reportPublic FDA data

MR Patient Care Neonatal Size 2 NBP Cuffs (10)

Primary DI
10884838120959
Brand
MR Patient Care Neonatal Size 2 NBP Cuffs (10)
Company
Philips Medizin Systeme Böblingen GmbH
Model
Neonatal Size 2 NBP Cuffs (10)
Catalog number
989803183181
Device description
NiBP Cuff, Single Lumen, Neo #2, Disp. Box of 10
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
10884838120959PrimaryGS10
00884838120952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088483812095910884838120959
00884838120952008848381209528848381209520884838120952

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57 KiloPascal102 KiloPascal
Storage Environment Atmospheric Pressure429 Millimeter of Mercury765 Millimeter of Mercury
Storage Environment Atmospheric Pressure570 millibar1020 millibar
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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
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
10884838113777MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
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
10884838129938MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2026-01-06
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
10884838111407MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2025-05-30
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