FDA.reportPublic FDA data

PFM PICC CT II

Primary DI
20813623017485
Brand
PFM PICC CT II
Company
PFM MEDICAL INCORPORATED
Model
PFM2CT4DN
Catalog number
PFM2CT4DN
Device description
4F (1.33mm) x 50cm DUAL LUMEN CT PICC NURSING KIT
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083873000PICC (CT RATED AND NON-RATED)Pfm Medical, Inc.2009-03-19LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813623017488PackageGS15In Commercial Distribution
20813623017485PackageGS120In Commercial Distribution
00813623017481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081362301748810813623017488
2081362301748520813623017485
00813623017481008136230174818136230174810813623017481

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607588749customerservice@pfmmedicalusa.

Regulatory Flags#

DUNS number
097736867
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00813623011144ASEPT Peritoneal Drainage System6222796222792016-10-01
00813623015371ASEPT Peritoneal Drainage SystemM7000M70002015-10-15
00813623017016ASEPT Pleural Drainage SystemM7001M70012016-10-02
00813623012066ASEPTM7050M70502016-10-05
00813623017054ASEPTM7005M70052019-03-31
00813623040878Jet-VacM7098M70982019-03-31
00813623040885Jet-VacM7097M70972019-03-31
00813623011267BBraun Multi-Snare6129706129702016-09-29
00813623011274BBraun Multi-Snare6129716129712016-09-29
00813623011281BBraun Multi-Snare6129726129722016-09-29
00813623011298BBraun Multi-Snare6129736129732016-09-29
00813623011304BBraun Multi-Snare6129746129742016-09-29
00813623011311BBraun Multi-Snare6129756129752016-09-29
00813623011328BBraun Multi-Snare6129766129762016-09-29
00813623010352Tita Jet616.368.3077-HAV616.368.3077-HAV2021-05-31
00813623010369Tita Jet616.368.2087-HAV616.368.2087-HAV2021-05-31
00813623010376Jet Port616.367.3077-HAV616.367.3077-HAV2021-05-31
00813623010383Jet Port616.367.2087-HAV616.367.2087-HAV2021-05-31
00813623010390Jet Port616.021.0078-HAV616.021.0078-HAV2021-05-31
00813623010406Tita Jet616.022.0078-HAV616.022.0078-HAV2021-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3R0031C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S900C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9150C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S920C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S9220C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S930C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S940C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S950C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H787MRC3S970C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
H965458160BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H965458560BioFloNAVILYST MEDICAL, INC.LJS2022-02-01
H96560M13031150BioFloNAVILYST MEDICAL, INC.LJS2021-06-24
H96560M13031130BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M13031160BioFloNAVILYST MEDICAL, INC.LJS2021-06-17
H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M0411560BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
H96560M13031110BioFloNAVILYST MEDICAL, INC.LJS2021-03-19
H954PKM033511S0BioFloNAVILYST MEDICAL, INC.LJS2021-03-08