ACIST Navvus® Catheter

GUDID 20841716100004

Navvus Catheter, p/n 701481-002

ACIST MEDICAL SYSTEMS, INC.

Catheter-tip transducer, pressure
Primary Device ID20841716100004
NIH Device Record Keye2e0f12d-91ba-47eb-b1af-9177b9662fa6
Commercial Distribution Discontinuation2019-04-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACIST Navvus® Catheter
Version Model Number014667
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110841716100007 [Primary]
GS120841716100004 [Package]
Contains: 10841716100007
Package: Inner box [5 Units]
Discontinued: 2019-04-10
Not in Commercial Distribution
GS130841716100650 [Package]
Package: Shelf box [1 Units]
Discontinued: 2019-04-10
Not in Commercial Distribution
GS130841716101220 [Package]
Package: Shelf box [1 Units]
Discontinued: 2019-04-10
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-06-12
Device Publish Date2016-09-09

On-Brand Devices [ACIST Navvus® Catheter]

10841716100014Navvus Catheter, p/n 701481-003
20841716100004Navvus Catheter, p/n 701481-002

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