FDA.reportPublic FDA data

NA

Primary DI
00885556632598
Brand
NA
Company
Smith & Nephew, Inc.
Model
7211011SR
Catalog number
7211011SR
Device description
SVCE REPL LEVELERT II FLUID LEVEL SENSOR
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556632598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556632598008855566325988855566325980885556632598

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)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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

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
03596010121233NASmith & Nephew, Inc.FLN2017-08-15
00885556561423NASmith & 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