FDA.reportPublic FDA data

IMed Products

Primary DI
10853155008387
Brand
IMed Products
Company
INTEGRATED MEDICAL SYSTEMS, INC.
Model
IM68135
Catalog number
IM68135
Device description
EVA Gravity Bag, 4000mL, 3 Legs
Published
2025-04-22
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
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030888000EVA EMPTY SOLUTION CONTAINERMetrix Co.2003-04-02KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853155008387PrimaryGS10
00853155008380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085315500838710853155008387
00853155008380008531550083808531550083800853155008380

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962364444
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136117eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
10612479272122McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272146McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272160McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272184McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272207McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272221McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272245McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21
10612479272269McKessonMCKESSON MEDICAL-SURGICAL INC.KPE2024-08-21