QuantaFlo

Primary DI
00859433006048
Brand
QuantaFlo
Company
SEMLER SCIENTIFIC, INC.
Model
91-0013
Device description
Application
Published
2016-08-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143094000QuantaFloSemler Scientific, Inc.2015-03-05JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859433006048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859433006048008594330060488594330060480859433006048

GMDN Terms#

Term, Definition table
TermDefinition
Limb plethysmographA graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968030333
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859433006000FloChec91-00042016-08-19
00859433006024QuantaFlo91-00102016-08-19
00859433006031FloChec91-00112016-08-19
00859433006055FloChec91-00142016-08-19
00859433006062QuantaFlo91-00152016-08-19
00859433006079QuantaFlo91-00162016-08-19
00859433006123QuantaFlo52-01002016-08-19

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