FDA.reportPublic FDA data

FINAL ASSY 2100-REMOTE 18-BR

Primary DI
00816787020120
Brand
FINAL ASSY 2100-REMOTE 18-BR
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
300-0302-01
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944495000MODEL 3200 VASCULAR MINI-LABParks Medical Electronics, Inc.1995-06-02MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816787020120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787020120008167870201208167870201200816787020120

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac arrhythmia monitoring systemAn assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)547-6427twelker@parksmed.com

Regulatory Flags#

DUNS number
009041773
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816787024388Remote Control RF 2100 With Pads300-0378-012025-07-18
008167870243193.9MHz Pencil Probe 7 Foot ODU connector832-1391-012022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connector832-1811-012022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connector832-1831-012022-05-15
008167870243408.7MHz Pencil Probe 7 Foot ODU connector832-1871-012022-05-15
008167870243579.1MHz Pencil Probe 7 Foot ODU connector832-1911-012022-05-15
008167870243649.4MHz Pencil Probe 7 Foot ODU connector832-1941-012022-05-15
008167870243719.7MHz Pencil Probe 7 Foot ODU connector832-1971-012022-05-15
008167870243028.1 MHz Pencil Probe 7FT Contoured832-0810-332021-05-15
008167870200078.2MHZ PENCIL PROBE 841-A832-1820-212016-09-24
008167870204588.2MHZ AVIAN INFANT832-0820-112016-09-24
008167870204658.5MHZ AVIAN INFANT832-0850-112016-09-24
008167870204728.9MHZ AVIAN INFANT832-0890-112016-09-24
008167870204899.2MHZ AVIAN INFANT832-0920-112016-09-24
008167870204969.3MHZ AVIAN INFANT832-0930-112016-09-24
008167870205029.5MHZ AVIAN INFANT832-0950-112016-09-24
008167870205199.7MHZ AVIAN INFANT832-0970-112016-09-24
008167870205263.9MHZ PENCIL PROBE832-1390-112016-09-24
008167870205333.9MHZ PENCIL PROBE 7'832-1390-312016-09-24
008167870205403.9MHZ PENCIL PROBE 10'832-1390-412016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMHX2023-04-19