FDA.reportPublic FDA data

BMS-2135.17S

Primary DI
00850005864608
Brand
BMS-2135.17S
Company
PATHEN MEDICAL LLC
Model
BMS-2135.17S
Device description
Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,
Published
2019-09-09
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005864605PackageGS150In Commercial Distribution
00850005864608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000586460510850005864605
00850005864608008500058646088500058646080850005864608

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.

Contacts#

Phone, Email table
PhoneEmail
8773185421questions@pathen.com

Regulatory Flags#

DUNS number
042928915
Device count
1
Lot or batch
true
Expiration date on label
true

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
00850005864646PS-84320PS-843202019-11-08
20850005864640PS-84320PS-843202019-11-08
00850005864615PS-843242PS-8432422019-11-05
00850005864622PS-84326PS-843262019-11-05
00850005864639PS-843262PS-8432622019-11-05

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Primary DI, Brand, Company table
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