FDA.reportPublic FDA data

Medline

Primary DI
30197344028959
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
PIVA20125
Catalog number
PIVA20125
Device description
IV CATH, AUTO, 20G X 1.25
Published
2023-11-10
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
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
20197344028952PackageGS150In Commercial Distribution
30197344028959PackageGS1200In Commercial Distribution
10197344028955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734402895220197344028952
3019734402895930197344028959
1019734402895510197344028955

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 Dry. Keep away from sunlight. Protect from freezing, Avoid excessive heat

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
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
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20801902219484ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219514ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30197344181517MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344181527MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344199690MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20801902225478ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225485ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225492ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
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20801902219392ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
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20801902219439ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
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20801902219507ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
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20801902219538ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219545ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219569ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219576ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219583ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219590ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
30382903836483NexivaBECTON, DICKINSON AND COMPANYFOZ2026-02-17