HydroPICC Basic Kit (130cm GW) 80001001

GUDID 00862559000456

Peripherally Inserted Central Catheter (Basic Kit with 130cm GW)

ACCESS VASCULAR, INC.

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Primary Device ID00862559000456
NIH Device Record Keye84b499f-c2fb-4d4d-b3c0-279069ada7a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydroPICC Basic Kit (130cm GW)
Version Model Number80001001
Catalog Number80001001
Company DUNS085539114
Company NameACCESS VASCULAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100862559000456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-25
Device Publish Date2021-10-15

On-Brand Devices [HydroPICC Basic Kit (130cm GW)]

00862559000456Peripherally Inserted Central Catheter (Basic Kit with 130cm GW)
00850030354228Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)
00850030354280Peripherally Inserted Central Marked Catheter (Basic Kit with 130cm GW)

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