FDA.reportPublic FDA data

DOPPLER MODEL 909

Primary DI
00816787024074
Brand
DOPPLER MODEL 909
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
909(F)
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
DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816787024074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787024074008167870240748167870240740816787024074

GMDN Terms#

Term, Definition table
TermDefinition
Laser Doppler blood flowmeterA mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.

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
Premarket exempt
true
Kit
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

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10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
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