AccessGUDID - DEVICE: AcQCross Qx (00850027837161)

GUDID

Device Identifier (DI) Information

Brand Name: AcQCross Qx
Version or Model: 900305
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900305
Company Name: ACUTUS MEDICAL, INC.

Primary DI Number: 00850027837161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844418199 *Terms of Use

Device Description: AcQCross Qx - MAX 70cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65073	Cardiac transseptal access electrosurgical dilator/needle	A luminal, one-piece, electrosurgical device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum for left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube that is curved and round-nosed at the distal end for positioning against the atrial septum, and incorporates an extendable, sharp needle in its lumen able to apply radio-frequency (RF) alternating current in a monopolar configuration. It may have radiopaque markers for positioning and enable acquisition of an intracardiac electrocardiogram (ECG); a guidewire and connection cables may also be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 880ad66d-9319-4049-b01b-5f3387d4db1e
Public Version Date: October 18, 2021
Public Version Number: 1
DI Record Publish Date: October 08, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (442)232-6100
Email: product.complaints@acutus.com

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