AccessGUDID - DEVICE: ASCENT (00878528001928)

GUDID

Device Identifier (DI) Information

Brand Name: ASCENT
Version or Model: BRS000407-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BRS00040700
Company Name: Medos International Sàrl

Primary DI Number: 00878528001928
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 7mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter

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:	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
MJN	Catheter, intravascular occluding, temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103780	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
Handling Environment Temperature: less than 55 Degrees Celsius
Storage Environment Temperature: less than 55 Degrees Celsius
Storage Environment Temperature: less than 131 Degrees Fahrenheit
Handling Environment Temperature: less than 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df78884f-ec4a-4c63-8c4e-fa601fc91d8b
Public Version Date: December 04, 2023
Public Version Number: 6
DI Record Publish Date: June 30, 2016