FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344029679
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
PIVA26056
Catalog number
PIVA26056
Device description
IV CATH, AUTO, 26G X 0.56
Published
2024-09-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230616000Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited2023-05-05FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344029676PackageGS150In Commercial Distribution
30197344029673PackageGS14In Commercial Distribution
10197344029679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734402967620197344029676
3019734402967330197344029673
1019734402967910197344029679

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.Protect from freezing. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14

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Primary DI, Brand, Company table
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00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
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