FDA.reportPublic FDA data

NIBP Cuffs

Primary DI
20884838114863
Brand
NIBP Cuffs
Company
Philips Medizin Systeme Böblingen GmbH
Model
GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE
Catalog number
M4578B
Device description
Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition
Published
2025-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OEDAntimicrobial Blood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEDAntimicrobial Blood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838114863PrimaryGS10
00884838114869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483811486320884838114863
00884838114869008848381148698848381148690884838114869

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference45Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 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
20884838114801NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
00884838114807NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
00884838114869NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
20884838114825NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114832NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114849NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114856NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114722NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114739NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114746NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114753NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114760NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114777NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114784NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114791NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009066NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009080NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009103NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838009127NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114818NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-14
00884838009042NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-14
10195594168353CARDINAL HEALTHCardinal Health 200, LLCOED2021-06-16
50195594168351CARDINAL HEALTHCardinal Health 200, LLCOED2021-06-16
20884838009022NIBP CuffsPhilips Medical Systems HsgOED2021-05-10
20884838009145NIBP CuffsPhilips Medical Systems HsgOED2021-05-10
00883873870211LIFEPAK 15 monitor/defibrillatorPHYSIO-CONTROL, INC.OED2019-05-23
00883873870259LIFEPAK 15 monitor/defibrillatorPHYSIO-CONTROL, INC.OED2019-05-23
00883873870297LIFEPAK 15 monitor/defibrillatorPHYSIO-CONTROL, INC.OED2019-05-23
00883873870303LIFEPAK 15 monitor/defibrillatorPHYSIO-CONTROL, INC.OED2019-05-23
00883873870358LIFEPAK 15 monitor/defibrillatorPHYSIO-CONTROL, INC.OED2019-05-23