AccessGUDID - DEVICE: FreeClimb 54 x 148 cm Access System (00853799007640)

GUDID

Device Identifier (DI) Information

Brand Name: FreeClimb 54 x 148 cm Access System
Version or Model: Gen 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: REF 6002
Company Name: ROUTE 92 MEDICAL

Primary DI Number: 00853799007640
Issuing Agency: GS1
Commercial Distribution End Date: October 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 067429673 *Terms of Use

Device Description: FreeClimb 54 x 148 cm Access System: Contains Tenzing 5 delivery catheter (00853799007619) and FreeClimb 54 x 148 cm Catheter (00853799007626)

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJP	Catheter, Percutaneous, Neurovasculature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231583	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a74e839-c84c-4e7b-a77a-4f05eb04c2a8
Public Version Date: May 24, 2024
Public Version Number: 1
DI Record Publish Date: May 16, 2024