FDA.reportPublic FDA data

Hometa

Primary DI
00850024592070
Brand
Hometa
Company
Hometa, Inc.
Model
G-G10-1A03
Device description
Drip Assist
Published
2020-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K150687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150687000DripAssistShift Labs2015-10-13FLN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850024592077PackageGS140In Commercial Distribution
00850024592070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002459207710850024592077
00850024592070008500245920708500245920700850024592070

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous gravity infusion monitorAn electronic device intended to monitor and display the volume and flow rate of intravenous (IV) fluids administration during gravity infusion, providing an alarm (visible/audible) when pre-set limits are exceeded. It is attached directly to the drip chamber of the infusion set and functions by means of a sensor (drop counter) designed to measure the amount of fluid passing through the infusion line and/or by measuring the weight of the fluid container. It includes a display screen, and may record data and be capable of wireless connectivity for data transfer.

Contacts#

Phone, Email table
PhoneEmail
5189925044raza.mohammed@hometa.com

Regulatory Flags#

DUNS number
117613680
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024592001Hometa 600082020-11-30
10850024592008Hometa 600082020-11-30
00850024592018Hometa600092020-11-14
00850024592025Hometa600102020-11-14
00850024592032Hometa600112020-11-14
00850024592049Hometa600122020-11-14
00850024592056Hometa600132020-11-14
00850024592063Hometa600142020-11-14

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