ACIST Navvus®II Catheter

GUDID 10841716103244

Navvus II Catheter, p/n 701711-003

ACIST MEDICAL SYSTEMS, INC.

Catheter-tip transducer, pressure
Primary Device ID10841716103244
NIH Device Record Key3a970bc8-faa7-49a8-8311-effb788bbf08
Commercial Distribution StatusIn Commercial Distribution
Brand NameACIST Navvus®II Catheter
Version Model Number016675
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841716102483 [Previous]
GS110841716103244 [Primary]
GS120841716103241 [Package]
Package: Shelf Box [5 Units]
In Commercial Distribution
GS130841716103248 [Package]
Contains: 20841716103241
Package: Ship Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBICatheter, Pressure Monitoring, Cardiac

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-28
Device Publish Date2025-01-20

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

10841716103480 - CT Exprès Patient Set2025-08-25 CT Exprès Patient Set
10841716103602 - ACIST Kodama® Coronary Imaging Catheter2025-08-22 Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag
10841716103244 - ACIST Navvus®II Catheter2025-01-28Navvus II Catheter, p/n 701711-003
10841716103244 - ACIST Navvus®II Catheter2025-01-28 Navvus II Catheter, p/n 701711-003
10841716103763 - ACIST RXi® Console with dPR2025-01-28 RXi Console with dPR, US (p/n: 800939-010 )
40841716103757 - ACIST RXi® System with dPR2025-01-28 RXi System with dPR, US (p/n: 800981-010 )
30841716103514 - ACIST HDi® System Console2024-11-21 HDi System Console
30841716103521 - ACIST HDi® Power Supply2024-11-21 HDi Power Supply
40841716103511 - ACIST HDi® HD IVUS System2024-11-21 HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.