FDA.reportPublic FDA data

Hometa

Primary DI
10850024592008
Brand
Hometa
Company
Hometa, Inc.
Model
60008
Device description
Empty EVA Bag 150 mL
Published
2020-11-30
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
10850024592008PackageGS150In Commercial Distribution
00850002046281PreviousGS10
00850024592001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002459200810850024592008
00850002046281008500020462818500020462810850002046281
00850024592001008500245920018500245920010850024592001

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5189925044raza.mohammed@hometa.com

Regulatory Flags#

DUNS number
117613680
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033629446Acta MedicalActa Medical LLCKPE2026-02-26
18056209145102EVA TPN BAGSVALMED SRLKPE2026-02-02
18056209145119EVA TPN BAGSVALMED SRLKPE2026-02-02
28033737862289EVA TPN BagsVALMED SRLKPE2025-12-31
38859299136135eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
38859299136142eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
38859299136159eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
10192253056709ChemoPlusCardinal Health 200, LLCKPE2025-08-22
10192253056716ChemoPlusCardinal Health 200, LLCKPE2025-08-22
38859299136173eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
38859299136036eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136043eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136067eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136074eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136081eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
38859299136111eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
00860013851200International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851217International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851224International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851231International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851248International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851255International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851262International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
00860013851279International Filter Products, doing business as IFP MedicalINTERNATIONAL FILTER PRODUCTS, INC.KPE2025-05-09
10810110921198IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10810110921204IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10810110921211IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10853155008370IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
10853155008387IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22
20853155008292IMed ProductsINTEGRATED MEDICAL SYSTEMS, INC.KPE2025-04-22