FDA.reportPublic FDA data

NA

Primary DI
00885556704127
Brand
NA
Company
Smith & Nephew, Inc.
Model
7211011F
Catalog number
7211011F
Device description
RFB LEVELERT II FLIUD LEVEL SENSOR
Published
2017-10-26
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
00885556704127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556704127008855567041278855567041270885556704127

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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

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
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
03596010556011LEVELERTSmith & Nephew, Inc.FLN2015-08-30