FDA.report

8.2MHZ SKNY PEN PROBE

Primary DI
00816787022018
Brand
8.2MHZ SKNY PEN PROBE
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
832-2820-11
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOPTRANSDUCER, ULTRASONIC

Product Code Classifications

CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816787022018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787022018008167870220188167870220180816787022018

GMDN Terms

TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)547-6427twelker@parksmed.com

Regulatory Flags

DUNS number
009041773
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
0081678702427219-B IR REMOTE RECEIVER300-0376-002018-10-08
00816787024289REFURBISHED 19-B IR REMOTE RECEIVER301-0376-002018-10-08
0081678702010618-B IR REMOTE RECEIVER300-0277-012016-09-24
0081678702011318-B REFURB. IR REMOTE REC.300-0277-252016-09-24
00816787020120FINAL ASSY 2100-REMOTE 18-BR300-0302-012016-09-24
008167870201372100-SX & 3100-B REMOTE CHARG-300-0314-012016-09-24
00816787020144REFURBISHED 18-BR REMOTE301-0302-002016-09-24
00816787020151REFURBISHED 2100-SX/3100-B IR301-0314-002016-09-24
008167870241732100-SX2 FINAL FEATURE ITEM2100-SX2 FFI2016-09-24
008167870200078.2MHZ PENCIL PROBE 841-A832-1820-212016-09-24
00816787020014DOPPLER MODEL 1050-C W/PPG1050-C2016-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880533Falcon/XpressVIASONIX LTDJOP2024-12-27
07290016880489Pressure Cuff Size 12LVIASONIX LTDJOP2023-06-29
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243408.7MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243579.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243649.4MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243719.7MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243028.1 MHz Pencil Probe 7FT ContouredPARKS MEDICAL ELECTRONICS, INC.JOP2021-05-15
0729001688007610 MHz probe VIASONIX LTDJOP2020-06-19
07290016880168Toe Clip PPG Sensor VIASONIX LTDJOP2020-06-19
07290016880175Disk PPG sensor VIASONIX LTDJOP2020-06-19
07290016880182Fingerclip PPG sensor VIASONIX LTDJOP2020-06-19
00894912002883Pencil probeKOVEN TECHNOLOGY, INC.JOP2018-04-10
00861446000401VascuLabUS VASCULAR LLCJOP2017-05-15
20884838003426NAPhilips Medical SystemsJOP2017-05-01
07290016880007FalconVIASONIX LTDJOP2016-11-21
07290016880014FalconVIASONIX LTDJOP2016-11-21