AccessGUDID - DEVICE: CELLO™, Balloon Guide Catheter (04544050120722)

GUDID

Device Identifier (DI) Information

Brand Name: CELLO™, Balloon Guide Catheter
Version or Model: 1610570
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJI SYSTEMS CORPORATION

Primary DI Number: 04544050120722
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 715919973 *Terms of Use
Previous DI: 04544050093460

Device Description: The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

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?
32584	Intravascular occluding balloon catheter, image-guided	A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120781	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: less than 54 Degrees Celsius
Special Storage Condition, Specify: Store in a cool, dry, dark place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7F
Outer Diameter: 2.4 Millimeter
Catheter Inner Diameter: 1.70 Millimeter
Shaft Length: 950 Millimeter

Device Record Status

Public Device Record Key: 6304d0ca-32b4-4e56-b33c-cfc8d637c93b
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: January 18, 2022