AcQGuide Mini-S 012852

GUDID 00857042007500

AcQGuide Mini-S, 65cm - L2 with AcQCross QX

ACUTUS MEDICAL, INC.

Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set
Primary Device ID00857042007500
NIH Device Record Key9ddfac59-3206-4991-a732-c10362c8e9ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcQGuide Mini-S
Version Model Number012852
Catalog Number012852
Company DUNS844418199
Company NameACUTUS MEDICAL, 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

Customer Support Contacts

Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857042007500 [Primary]

FDA Product Code

DYBIntroducer, Catheter

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

Devices Manufactured by ACUTUS MEDICAL, INC.

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00850027837765 - FlexCath Cross Transseptal Solution2023-09-11 FlexCath Cross Transseptal Solution– AG 71 cm
00850027837789 - FlexCath Cross Transseptal Solution2023-09-11 FlexCath Cross Transseptal Solution– SL 63 cm
00850027837802 - FlexCath Cross Transseptal Solution2023-09-11 FlexCath Cross Transseptal Solution– VZ 71 cm
00850027837826 - FlexCath Cross Transseptal Solution2023-09-11 FlexCath Cross Transseptal Solution– FC 65 cm
00850027837840 - FlexCath Cross Transseptal Solution2023-09-11 FlexCath Cross Transseptal Solution– MAX 70 cm

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