FDA.reportPublic FDA data

IMed Products

Primary DI
10810110920344
Brand
IMed Products
Company
INTEGRATED MEDICAL SYSTEMS, INC.
Model
IM250250S
Catalog number
IM250250S
Device description
IMed Elastomeric Pump - 250mL/250mL per Hour
Published
2025-04-16
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
K151650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151650000SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.2016-04-04MEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810110920344PackageGS124In Commercial Distribution
00810110920347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011092034410810110920344
00810110920347008101109203478101109203470810110920347

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
962364444
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810110920160IMed ProductsIM1250IM12502025-05-06
10810110920702IMed ProductsIM1266CKIM1266CK2025-05-06
10853155008684IMed ProductsIM36026IM360262025-04-16
00853155008878IMed ProductsIM54085IM540852025-07-03
00853155008885IMed ProductsIM54086IM540862025-07-03
00853155008892IMed ProductsIM54087IM540872025-07-03
00853155008908IMed ProductsIM54088IM540882025-07-03
00853155008915IMed ProductsIM54089IM540892025-07-03
00853155008939IMed ProductsIM54091IM540912025-07-03
10853155008875IMed ProductsIM54085IM540852025-07-03
10853155008882IMed ProductsIM54086IM540862025-07-03
10853155008899IMed ProductsIM54087IM540872025-07-03
10853155008905IMed ProductsIM54088IM540882025-07-03
10853155008912IMed ProductsIM54089IM540892025-07-03
10853155008936IMed ProductsIM54091IM540912025-07-03
00810110920163IMed ProductsIM1250IM12502025-05-06
00810110920705IMed ProductsIM1266CKIM1266CK2025-05-06
10810110921198IMed ProductsIM68055IM680552025-04-22
10810110921204IMed ProductsIM68100IM681002025-04-22
10810110921211IMed ProductsIM68102IM681022025-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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