FDA.reportPublic FDA data

POCKET DOPPLER MODEL 842

Primary DI
00816787024043
Brand
POCKET DOPPLER MODEL 842
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
842
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

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
00816787024043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787024043008167870240438167870240430816787024043

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
HCT/P
false
Kit
true
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 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
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

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