AccessGUDID - DEVICE: Vasoshield (00607567700468)

GUDID

Device Identifier (DI) Information

Brand Name: Vasoshield
Version or Model: VH-5001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VH-5001
Company Name: MAQUET CARDIOVASCULAR LLC

Primary DI Number: 00607567700468
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022348156 *Terms of Use

Device Description: Vasoshield Pressure Controlling Syringe

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?
47798	Vascular irrigation cannula, cardiac vessel graft	A sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots after resection. It is typically made of plastic material (e.g., polypropylene) and typically designed with a connector at the proximal end (e.g., is attached to a syringe with a Luer connector) and a ribbed flange at the distal end for a secure connection to the vessel. It may also be used to perfuse the heart through the graft after having done the anastomosis on the coronary artery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	Catheter, Irrigation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: d3327ffb-963a-45a3-b776-7a243224e697
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20607567700462	5	00607567700468		In Commercial Distribution	5 pack box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-880-2874
Email: cssurgery@maquet.com

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