AccessGUDID - DEVICE: VasQ (07290016063325)

GUDID

Device Identifier (DI) Information

Brand Name: VasQ
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG0032
Company Name: LAMINATE MEDICAL TECHNOLOGIES LTD

Primary DI Number: 07290016063325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600196773 *Terms of Use

Device Description: External support for vascular access arteriovenous fistulas

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
62497	Arteriovenous fistula extraluminal mesh-sleeve	A non-bioabsorbable, implantable device intended to be used for the extraluminal (external) support of an arteriovenous fistula (AVF) to facilitate viable maturation and patency of the AVF for haemodialysis. It is a metal mesh structure intended to improve the characteristics of the AVF (e.g., luminal uniformity, flow capability, luminal strength/stability) to reduce the risk of failure from adverse events such as thrombosis, intimal hyperplasia, and stenosis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access

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: 57047340-facb-48d7-a99f-b9c8741a96d9
Public Version Date: February 28, 2024
Public Version Number: 2
DI Record Publish Date: November 26, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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