FDA.reportPublic FDA data

NA

Primary DI
03596010121233
Brand
NA
Company
Smith & Nephew, Inc.
Model
3982S
Catalog number
3982S
Device description
SVCE REPL LEVELERT SENSOR W/CORD
Published
2017-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLNMONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLNMonitor, Electric For Gravity Flow Infusion SystemsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903193000SMITH & NEPHEW DYONICS LEVELERT SYSTEMSmith & Nephew Dyonics, Inc.1990-08-30FLN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010121233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010121233035960101212333596010121233

GMDN Terms#

Term, Definition table
TermDefinition
Electronic gravity infusion controllerAn electrically-powered device intended to be used to control and monitor the gravity infusion of intravenous (IV) fluids, providing an alarm (visible/audible) when pre-set limits are exceeded. It is available in two main configurations: 1) a device with an electronic flow sensor (drop counter) that monitors/measures the amount of fluid that passes through the infusion line; or 2) a device that measures the weight of the fluid container and may assist in bolus administration. The predetermined values may be selected by the user, and the device may display flow rate, total volume, and may record data. Some types can be used during arthroscopic procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845699046447Agiliti - EssentiaSIZEWISE RENTALS, L.L.C.FLN2026-05-08
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHFLN2021-03-08
00850024592070HometaHometa, Inc.FLN2020-11-05
00885556704127NASmith & Nephew, Inc.FLN2017-10-26
00885556561423NASmith & Nephew, Inc.FLN2017-08-15
00885556632598NASmith & Nephew, Inc.FLN2017-08-15
00885556571071NASmith & Nephew, Inc.FLN2017-06-15
00856220006007DripAssistSHIFT LABS, INC.FLN2016-04-01
03596010121196NASmith & Nephew, Inc.FLN2015-08-30
03596010121202NASmith & Nephew, Inc.FLN2015-08-30
03596010556011LEVELERTSmith & Nephew, Inc.FLN2015-08-30