FDA.reportPublic FDA data

SMARTeZ Pump KVO

Primary DI
28859299198136
Brand
SMARTeZ Pump KVO
Company
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Model
498131
Device description
SMARTeZ Pump KVO 50-0.5-100h
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEBPump, Infusion, Elastomeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEBPump, Infusion, ElastomericGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242152000SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.2024-10-07MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
48859299198130PackageGS112In Commercial Distribution
28859299198136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4885929919813048859299198130
2885929919813628859299198136

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump systemAn assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
662213220
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18859299123612eZSURE™426030SF2026-04-10
18859299123629eZSURE™426040SF2026-04-10
18859299123636eZSURE™426110SF2026-04-10
18859299124589eZSURE™426210SF2026-04-10
18859299184705SMARTeZ Fluid Transfer Set4700102026-04-08
18859299131013ProSeal CSTD4210102026-03-11
18859299131051ProSeal CSTD4210502026-03-11
18859299133857ProSeal CSTD4238502026-03-11
38859299131017ProSeal CSTD4210102026-03-11
38859299131055ProSeal CSTD4210502026-03-11
38859299133851ProSeal CSTD4238502026-03-11
28859299198129SMARTeZ Pump KVO4981212026-02-03
48859299198123SMARTeZ Pump KVO4981212026-02-03
48859299198130SMARTeZ Pump KVO4981312026-02-03
28859299198143SMARTeZ Pump KVO4981412026-02-03
68859299100045SMARTeZ Pump4800462025-11-14
18859299101177SMARTeZ Pump4811712025-11-14
78859299100042SMARTeZ Pump4800462025-11-14
18859299119950ProSeal CSTD423370ST2025-09-11
18859299124114ProSeal CSTD423840STWH2025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479280189McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280202McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280226McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280240McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280264McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280288McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280301McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280325McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280349McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280363McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280387McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280400McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280424McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280448McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280462McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479271323McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271347McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271361McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271385McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271408McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271422McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271446McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271460McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271484McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271507McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271521McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
10612479271545McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2024-07-20
08436020766404DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766411DOSI-PAINLEVENTON SAUMEB2018-12-31
08436020766428DOSI-PAINLEVENTON SAUMEB2018-12-31