FDA.reportPublic FDA data

PR-84214

Primary DI
20850005864237
Brand
PR-84214
Company
PATHEN MEDICAL LLC
Model
PR-84214
Device description
14g x 1 1/4” IV CATHETER PURSAFETY R
Published
2019-04-24
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
K150611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150611000MedSource ClearSafe Safety IV CatheterMedsource International2015-07-15FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005864230PackageGS150In Commercial Distribution
20850005864237PackageGS14In Commercial Distribution
00850005864233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000586423010850005864230
2085000586423720850005864237
00850005864233008500058642338500058642330850005864233

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular/subcutaneous catheterA sterile, dual-purpose, thin, flexible tube intended for: 1) insertion into the peripheral vasculature to enable short-term (< 30 days) intravascular access for blood sampling, blood pressure monitoring, fluid/medication administration and/or contrast media injection; and 2) administration of fluids/medication into subcutaneous tissue. It typically includes dedicated accessories to facilitate catheter introduction/function (e.g., connectors, injection ports, stylet, fixation wings, introduction needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8773185421questions@pathen.com

Regulatory Flags#

DUNS number
042928915
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005864233PR-84214PR-842142019-04-24
00850005864240PR-84216PR-842162019-04-24
00850005864257PR-84218PR-842182019-04-24
00850005864264PR-84220PR-842202019-04-24
00850005864271PR-842202PR-8422022019-04-24
00850005864288PR-84222PR-842222019-04-24
00850005864295PR-84224PR-842242019-04-24
00850005864301PS-84314PS-843142019-04-24
00850005864318PS-84316PS-843162019-04-24
00850005864325PS-84318PS-843182019-04-24
00850005864332PS-843182PS-8431822019-04-24
00850005864349PS-843202PS-8432022019-04-24
00850005864356PS-843203PS-8432032019-04-24
00850005864363PS-84322PS-843222019-04-24
00850005864370PS-84324PS-843242019-04-24
00850005864608BMS-2135.17SBMS-2135.17S2019-09-09
00850005864646PS-84320PS-843202019-11-08
20850005864640PS-84320PS-843202019-11-08
00850005864615PS-843242PS-8432422019-11-05
00850005864622PS-84326PS-843262019-11-05

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