FDA.reportPublic FDA data

SMARTeZ Pump KVO

Primary DI
48859299198130
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
662213220
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
28859299198136SMARTeZ Pump KVO4981312026-02-03
48859299198123SMARTeZ Pump KVO4981212026-02-03
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
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10612479280325McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
10612479280349McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
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10612479280400McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
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10612479280448McKessonMCKESSON MEDICAL-SURGICAL INC.MEB2025-11-19
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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