FDA.reportPublic FDA data

Ultracheck

Primary DI
10841522106866
Brand
Ultracheck
Company
Statcorp Medical
Model
UltraCheck BP Cuffs
Catalog number
BRUS3854MHP
Device description
BP CUFF, UC CURVE,1T,XL.ADULT,38-54CM,MHP,EA
Published
2016-12-15
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122365000ULTRACHECK CURVE BLOOD PRESSURE CUFFSStatcorp Medical2013-06-04OED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522106866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210686610841522106866

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 Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602075905
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522112126SoftcheckSoftCheck BP Cuffs3009167-0302016-12-01
10841522112188SoftcheckSoftCheck BP Cuffs3009167-0342016-12-01
10841522109577UltracheckUltraCheck BP CuffsUS1826MB2016-10-24
10841522109638UltracheckUltraCheck BP CuffsUS3544MB2016-10-24
10841522109898UltracheckUltraCheck BP CuffsUD1826MQ2016-10-19
10841522110009UltracheckUltraCheck BP CuffsUD2938MQ2016-10-19
10841522110061UltracheckUltraCheck BP CuffsUD3242MQ2016-10-19
10841522106576Statcorp MedicalSTATCORPUD0814MQMF2016-10-04
10841522107665UltracheckUltraCheck BP CuffsUS4250DM2016-10-04
10841522108228SoftcheckSoftCheck BP CuffsNN4DT2016-11-10
10841522108310SoftcheckSoftCheck BP CuffsVDT3544DM2016-10-24
10841522109119SoftcheckSoftCheck BP CuffsST1826DM2016-10-04
10841522109225SoftcheckSoftCheck BP CuffsST2635DM2016-10-04
10841522109270UltracheckUltraCheck BP CuffsUS1320MML2016-10-24
10841522109263SoftcheckSoftCheck BP CuffsST2635ML2016-12-07
10841522109133UltracheckUltraCheck BP CuffsN/A2016-12-15
10841522130458TrulinkABP Cuffs and Cuff Covers715-3021-002025-03-13
10841522130465TrulinkABP Cuffs and Cuff Covers715-3022-002025-03-13
10841522130472TrulinkABP Cuffs and Cuff Covers715-3031-002025-03-13
10841522130489TrulinkABP Cuffs and Cuff Covers715-3032-002025-03-13

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
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