FDA.reportPublic FDA data

INTRAVIA

Primary DI
20085412000040
Brand
INTRAVIA
Company
BAXTER INTERNATIONAL INC.
Model
2B8014
Catalog number
2B8014
Device description
INTRAVIA Container, 1000 mL Capacity
Published
2016-09-24
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964853000INTRAVIA CONTAINER, EMPTYBaxter Healthcare Corp1997-03-31KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20085412000040PackageGS16In Commercial Distribution
50085412000041PackageGS148In Commercial Distribution
00085412000046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2008541200004020085412000040
5008541200004150085412000041
00085412000046000854120000460854120000460085412000046

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Adhere to storage requirements of added medication.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
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
false
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
00085412002286INTERLINK/CONTINU-FLO2C65722C65722016-09-24
00085412002347INTERLINK2C66072C66072016-09-24
00085412002361INTERLINK2C66312C66312016-09-24
00085412003955INTERLINK2C66062C66062016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412013619INTERLINK1C83331C83332016-09-24
00085412014135INTERLINK1C84541C84542016-09-24
00085412017853INTERLINK/CONTINU-FLO3C00913C00912016-09-24
00085412051314CLEARLINK2N83772N83772016-09-24
00085412079677CLEARLINK/CONTINU-FLOACT8570ACT85702016-09-24
00085412079707CONTINU-FLO/DUO-VENTACT5543ACT55432016-09-24
00085412082592CLEARLINK/INTERLINK/DUO-VENTEMS3160EMS31602016-09-24
00085412000985Arthromatic/Uromatic2C40062C40062016-09-24
00085412001005Arthromatic/Uromatic2C40142C40142016-09-24
00085412014869Baxter1C86141C86142016-09-24
00085412000978Arthromatic/Uromatic2C40052C40052016-09-24
00085412001050Arthromatic/Uromatic2C40402C40402016-09-24
00085412001067Arthromatic/Uromatic2C40412C40412016-09-24
00085412004136Baxter2C76272C76272016-09-24
00085412027388VIAL-MATE2B80712B80712016-09-24

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