FDA.reportPublic FDA data

Remote Control RF 2100 With Pads

Primary DI
00816787024388
Brand
Remote Control RF 2100 With Pads
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
300-0378-01
Published
2025-07-18
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816787024388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787024388008167870243888167870243880816787024388

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)547-6427info@parksmed.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
008167870205574.0MHZ PENCIL PROBE832-1400-112016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785484Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785491Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675786108Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
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
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26