Low Profile Peripheral

GUDID 07640110981771

Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter

PFM MEDICAL INCORPORATED

Vascular port/catheter
Primary Device ID07640110981771
NIH Device Record Keyde5d14c0-4ab0-4e3d-af60-f30995920bff
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow Profile Peripheral
Version Model Number616.460.7080-A
Company DUNS097736867
Company NamePFM MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588749
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640110981771 [Package]
Contains: 07640110987742
Package: Box [20 Units]
In Commercial Distribution
GS107640110987742 [Primary]

FDA Product Code

LJTPort & Catheter, Implanted, Subcutaneous, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [Low Profile Peripheral]

76401109877426Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter
76401109877280Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
76401109877044Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter
07640110981771Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter
07640110981207Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
07640110981764Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter

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