FDA.reportPublic FDA data

ISO-MED

Primary DI
00075289522222
Brand
ISO-MED
Company
TRANZONIC COMPANIES, THE
Model
ISOEVA3000
Catalog number
ISOEVA3000
Device description
ISO-MED Sterile Empty EVA 2-Port Bags - 3000 mL 50/BX 4 BX/CS
Published
2026-06-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPEContainer, I.V.

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70075289522221PackageGS14In Commercial Distribution
00075289522222PrimaryGS10
10075289522229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
7007528952222170075289522221
00075289522222000752895222220752895222220075289522222
1007528952222910075289522229

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
007900020
Device count
50
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075289522178ISO-MEDISOEVA100ISOEVA1002026-06-22
00075289522185ISO-MEDISOEVA1000ISOEVA10002026-06-22
00075289522192ISO-MEDISOEVA150ISOEVA1502026-06-22
00075289522208ISO-MEDISOEVA2000ISOEVA20002026-06-22
00075289522215ISO-MEDISOEVA250ISOEVA2502026-06-22
00075289522239ISO-MEDISOEVA4000ISOEVA40002026-06-22
00075289522246ISO-MEDISOEVA50ISOEVA502026-06-22
00075289522253ISO-MEDISOEVA500ISOEVA5002026-06-10
00653195276400Safety ZoneBRZ640BRZ6402020-04-16
00075289715532VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
00075289715549VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
00075289715556VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
00075289715563VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
00075289715570VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25
10075289715539VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
10075289715546VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
10075289715553VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
70075289715562VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
10075289715577VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25
10075289065009Comfort PlusCPCR200CPCR2002023-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075289522178ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522185ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522192ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522208ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522215ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522239ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522246ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522253ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-10
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