AccessGUDID - DEVICE: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System (08600035053013)

GUDID

Device Identifier (DI) Information

Brand Name: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Version or Model: 3001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3001
Company Name: East End Medical I LLC

Primary DI Number: 08600035053013
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 118148023 *Terms of Use

Device Description: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Small size.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
10747	Cardiac septostomy catheter, balloon	A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.	Active	false
65312	Cardiovascular catheter sheath	A sterile, noninvasive, flexible sleeve intended to be used during cardiovascular catheterization (e.g., femoral, pulmonary) to cover and protect the exposed proximal end of a cardiovascular catheter to prevent contamination (extending the sterile field of the external catheter) and/or to contain a backflow of blood (e.g., during catheter introduction, repositioning or removal). It is typically transparent and includes appropriate connectors for distal attachment to the catheter introducer, and proximal attachment to the extracorporeal portion of the catheter. Neither the catheter nor introduction/procedural devices are included (i.e., not a set). 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 [?]
K203459	000

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
Storage Environment Temperature: between -30 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 109 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edadb073-5845-45c0-bd8f-b67c73d0ca54
Public Version Date: May 30, 2025
Public Version Number: 3
DI Record Publish Date: April 05, 2022