FDA.reportPublic FDA data

PM007

Primary DI
00850005864530
Brand
PM007
Company
PATHEN MEDICAL LLC
Model
PM007
Device description
"7"" Macro Bore, extenstion set with pinch clamp"
Published
2019-07-23
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005864537PackageGS150In Commercial Distribution
00850005864530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000586453710850005864537
00850005864530008500058645308500058645300850005864530

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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
Manufacturing date on label
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
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