AccessGUDID - DEVICE: AcQCross Qx (00850027837109)

GUDID

Device Identifier (DI) Information

Brand Name: AcQCross Qx
Version or Model: 900302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900302
Company Name: ACUTUS MEDICAL, INC.

Primary DI Number: 00850027837109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844418199 *Terms of Use

Device Description: AcQCross Qx - SL 63cm

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: c3040e6e-62b2-4b4b-9941-928d747da91e
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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