FDA.reportPublic FDA data

ABPCare

Primary DI
00856298006176
Brand
ABPCare
Company
SCOTTCARE CORPORATION, THE
Model
ABPCare
Catalog number
101367
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSKComputer, Blood-Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021517000ABP FOR WINDOWSRozinn Electronics, Inc.2002-07-24DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856298006176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856298006176008562980061768562980061760856298006176

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory services information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of ambulatory care services [those services provided to patients on an ambulatory basis (e.g., in an emergency department, physician's office, urgent care centre), rather than by admission to a healthcare facility] and facilities. It is available for installation into existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-362-0550service@scottcare.com

Regulatory Flags#

DUNS number
808204957
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856298006411AermosAermos System2025-10-28
00856298006428EZLink-REZLink-R1032012024-05-23
00856298006435EZLink-CEZLink-C1032002024-05-23
00856298006282TeleRehab Receiver BoxTR6201011272016-09-19
00856298006299TeleRehab Receiver CardTeleRehab Receiver Card1000072016-09-19
00856298006114Transtelephonic Receiving ModuleTranstelephonic Receiving Module1001512016-09-19
00856298006046TeleSentry BatteryTS01101109B2017-01-11
00856298006077Telemetry 3 Lead Patient CableTelemetry 3 Lead Patient Cable1002332016-09-19
00856298006084Telemetry 5 Lead Patient CableTelemetry 5 Lead Patient Cable1002342016-09-19
00856298006091Chroma2 5 Lead Patient CableChroma2 5 Lead Patient Cable2016-09-19
00856298006107Chroma2 7 Lead Patient CableChroma2 7 Lead Patient Cable1019282016-09-19
00856298006121TeleSentry 3 Lead Patient CableTeleSentry 3 Lead Patient Cable1001722016-09-19
00856298006138"TeleSense 3 Lead Patient Cable 30""""TeleSense 3 Lead Patient Cable 30"""1018262016-09-19
00856298006145"TeleSense 3 Lead Patient Cable 40""""TeleSense 3 Lead Patient Cable 40"""1018732016-09-19
00856298006275TeleRehab ComputerTeleRehab Computer1018192016-09-19
00856298006008ChromaRZ153C1012732016-09-19
00856298006015Chroma2RZ153C21019422016-09-19
00856298006022TeleSenseRCMMCT17741018382016-09-19
00856298006039TeleSense-EE17741018392016-09-19
00856298006220Chroma 5 Lead Patient Cable1006052017-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSK2026-04-15
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDSK2025-12-09
00850022994456Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994463Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994470Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994487Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-06
00850022994524Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994531Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994548Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00850022994555Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-11-03
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FTPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGANPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00850022994401Zurich Medical Accessory CableZURICH MEDICAL INC.DSK2025-09-08
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-08-22
00845225011420Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationDSK2025-03-24
00845225012762IVUS-PIMPhilips Image Guided Therapy CorporationDSK2025-03-24
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
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00847946080600PROPAQ MZoll Medical CorporationDSK2024-03-06
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