FDA.reportPublic FDA data

PiSA BioPharm

Primary DI
00850002046410
Brand
PiSA BioPharm
Company
PISA BIOPHARM INC.
Model
60014
Device description
Empty EVA Bag 4000 mL
Published
2020-01-10
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
00850002046410PackageGS140In Commercial Distribution
00850002046403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002046410008500020464108500020464100850002046410
00850002046403008500020464038500020464030850002046403

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@pisa-biopharm.com

Regulatory Flags#

DUNS number
080043343
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
00850002046281PiSA BioPharm600082020-01-10
00850002046304PiSA BioPharm600092020-01-10
00850002046328PiSA BioPharm600102020-01-10
00850002046342PiSA BioPharm600112020-01-10
00850002046366PiSA BioPharm600122020-01-10
00850002046403PiSA BioPharm600142020-01-10
00850002046298PiSA BioPharm600082020-01-10
00850002046311PiSA BioPharm600092020-01-10
00850002046335PiSA BioPharm600102020-01-10
00850002046359PiSA BioPharm600112020-01-10
00850002046373PiSA BioPharm600122020-01-10
00850002046380PiSA BioPharm600132020-01-10
00850002046014PiSA BioPharm 6002022018-09-24
00850002046021PiSA BioPharm 6002032018-09-24
00850002046038PiSA BioPharm 6002042018-09-24
00850002046045PiSA BioPharm 6002052018-09-24
00850002046052PiSA BioPharm 6002062018-09-24
00850002046182PiSA BioPharm600032019-03-07
00850002046205PiSA BioPharm600042019-03-07
00850002046212PiSA BioPharm 600052019-03-07

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
00075289522222ISO-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