FDA.reportPublic FDA data

NIBP Cuffs

Primary DI
20884838037537
Brand
NIBP Cuffs
Company
Philips Medical Systems Hsg
Model
Single Care Cuff, Small Adult
Catalog number
989803182291
Device description
Single Care Cuff, Small Adult (light blue). Single Patient. Circumference 20.5 - 28.5 cm. 20 cuffs per box.
Published
2017-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEDAntimicrobial blood pressure cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEDAntimicrobial Blood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071885000ANTIMICROBIAL AND SINGLE-PATIENT CUFFSPhilips Medical Systems2007-12-20OED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838037537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088483803753720884838037537

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
Circumference28.5Centimeter

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

Contacts#

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

Regulatory Flags#

DUNS number
790605856
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838015245HeartStartExternal Paddles Water ResistantM3543A2014-09-24
00884838090088MX40 Masimo Leadsets and AdaptersMX40 Adapter 5-Lead + Masimo SpO29898032023812022-05-23
00884838090095MX40 Masimo Leadsets and AdaptersMX40 Adapter Masimo SpO2-only9898032023912022-05-23
00884838090101MX40 Masimo Leadsets and AdaptersECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112020-04-21
00884838090118MX40 Masimo Leadsets and AdaptersECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212020-04-21
00884838091276MX40 Masimo Leadsets and AdaptersMX40 Adapter 6-Lead + Masimo SpO29898032042912020-04-21
00884838013360ECG ElectrodesCBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE9898031718112017-07-13
00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
00884838013391ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE9898031718412016-09-27
00884838013407ECG ElectrodesCBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE9898031718512016-09-27
00884838013414ECG ElectrodesCBL ECG 6 LEAD GRABBER, AAMI, TELE9898031718612017-07-27
20884838013517ECG ElectrodesCBL ECG 5 LEAD GRABBER IEC, SPU, TELE9898031721312020-03-25
20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13
00884838013476ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC, TELE9898031719612016-11-01
00884838013483ECG ElectrodesCBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE9898031719712016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
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