FDA.reportPublic FDA data

FlowMet™

Primary DI
00860001276114
Brand
FlowMet™
Company
MEDTRONIC, INC.
Model
FMET-IM-SENS-5
Device description
SENSOR FMET-IM-SENS-5
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192966000FlowMetLaser Associated Sciences, Inc.2020-01-10DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860001276111PackageGS15In Commercial Distribution
00860001276114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000127611110860001276111
00860001276114008600012761148600012761140860001276114

GMDN Terms#

Term, Definition table
TermDefinition
Laser speckle blood flowmeter An electrically-powered device designed to use laser speckle imaging to measure micro- and macrovascular blood circulation and to assess the extent of vascular flow and associated changes [i.e., due to clots, stenosis, vascular tone changes, mechanical damage, and peripheral vascular disease (PVD)]. It uses laser light projected onto tissue and a multi-element light detector (e.g., a digital camera) to detect remitted light, thus enabling a measure of spatial variation (map) of blood flow. The device typically consists of one or more optical sensors connected to a software-controlled control/visual display unit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Altitude (storage and transport) -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Relative humidity storage 50% noncondensing
Special Storage Condition, Specify00Relative humidity transport 20% to 80% noncondensing
Special Storage Condition, Specify00Temperature storage 73°F (23°C)
Special Storage Condition, Specify00Temperature transport 32°F to 122°F (0°C to 50°C)

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

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