FDA.reportPublic FDA data

FlowMet™

Primary DI
10860001276111
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
OTC
false
Sterile
false
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)

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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