AccessGUDID - DEVICE: Hemashield (00384401018674)

GUDID

Device Identifier (DI) Information

Brand Name: Hemashield
Version or Model: M00202175732P0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M00202175732P0
Company Name: INTERVASCULAR SAS

Primary DI Number: 00384401018674
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 382174019 *Terms of Use

Device Description: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Accessory

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:	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?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAL	Graft, Vascular, Synthetic/Biologic Composite

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021213	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: Controlled Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 10 Millimeter
Lumen/Inner Diameter: 12 Millimeter
Lumen/Inner Diameter: 32 Millimeter
Length: 50 Centimeter

Device Record Status

Public Device Record Key: 686c33fc-41f0-4ce5-a1b4-7542291a3e4c
Public Version Date: September 24, 2025
Public Version Number: 6
DI Record Publish Date: November 09, 2015