FDA.report

MEDLINE

Primary DI
20197344104151
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
PIVBCA20175
Catalog number
PIVBCA20175
Device description
IV CATH, BC, AUTO, 20G X 1.75
Published
2025-02-06
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

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K230616000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230616000Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited2023-05-05FOZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344104151PackageGS150In Commercial Distribution
30197344104158PackageGS14In Commercial Distribution
10197344104154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734410415120197344104151
3019734410415830197344104158
1019734410415410197344104154

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods

Method

Contacts

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

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