FDA.report

POCKET DOPPLER MODEL 840

Primary DI
00816787023978
Brand
POCKET DOPPLER MODEL 840
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
840(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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816787023978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787023978008167870239788167870239780816787023978

GMDN Terms

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

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
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

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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
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008167870241732100-SX2 FINAL FEATURE ITEM2100-SX2 FFI2016-09-24
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