FDA.reportPublic FDA data

LEVELERT

Primary DI
03596010556011
Brand
LEVELERT
Company
Smith & Nephew, Inc.
Model
7211011
Catalog number
7211011
Device description
LEVELERT II FLUID LEVEL SENSOR
Published
2015-08-30
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010556011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010556011035960105560113596010556011

GMDN Terms#

Term, Definition table
TermDefinition
Infusion controller, line-poweredA mains electricity (AC-powered) device 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)821-5700gudid@smith-nephew.com
+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
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

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
03596010121233NASmith & Nephew, Inc.FLN2017-08-15
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