AccessGUDID - DEVICE: Fusion Bioline Vascular Grafts (00384409005805)

GUDID

Device Identifier (DI) Information

Brand Name: Fusion Bioline Vascular Grafts
Version or Model: M00201501041B0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M00201501041B0
Company Name: MAQUET CARDIOVASCULAR LLC

Primary DI Number: 00384409005805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022348156 *Terms of Use

Device Description: Fusion Bioline 10mm-40cm Unsupp Peripher

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131778	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
Special Storage Condition, Specify: Store at Controlled Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Centimeter
Lumen/Inner Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: a262b676-cf46-427c-825e-7efc431b411d
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 24, 2015