FDA.reportPublic FDA data

FlowMet™

Primary DI
00763000502843
Brand
FlowMet™
Company
MEDTRONIC, INC.
Model
FMET-IM-SYS-S
Device description
SYSTEM SERVICED FMET-IM-SYS-S
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
00763000502843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000502843007630005028437630005028430763000502843

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 -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
Special Storage Condition, Specify00Relative humidity 20% to 80% noncondensing
Special Storage Condition, Specify00Temperature 32°F to 122°F (0°C to 50°C)

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

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