FDA.reportPublic FDA data

NIBP Cuffs

Primary DI
00884838009103
Brand
NIBP Cuffs
Company
Philips Medizin Systeme Böblingen GmbH
Model
GENTLE CARE CUFF, ADULT XL, 1-TUBE
Catalog number
M4576B
Device description
Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition
Published
2025-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
20884838114849PrimaryGS10
00884838009103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483811484920884838114849
00884838009103008848380091038848380091030884838009103

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
Circumference36Centimeter
Device Size Text, specify0

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101143
Device count
10
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838114801NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
20884838114863NIBP 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
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