HydroPICC Maximal Barrier Kit 80001004

GUDID 00862559000494

Peripherally Inserted Central Catheter (Maximal Barrier Kit)

ACCESS VASCULAR, INC.

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Primary Device ID00862559000494
NIH Device Record Keydc831d39-d0ef-42ac-b289-c9251b775450
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydroPICC Maximal Barrier Kit
Version Model Number80001004
Catalog Number80001004
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
GS100862559000494 [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 Maximal Barrier Kit]

00862559000494Peripherally Inserted Central Catheter (Maximal Barrier Kit)
00850030354242Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)
00850030354303Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit)

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