VasQ

Primary DI
07290016063349
Brand
VasQ
Company
LAMINATE MEDICAL TECHNOLOGIES LTD
Model
4
Catalog number
FG0034
Device description
External support for vascular access arteriovenous fistulas
Published
2023-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVQExtravascular Support For An Arteriovenous Fistula For Vascular AccessCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220026000VasQLaminate Medical Technologies , Ltd.2023-09-26QVQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016063349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016063349072900160633497290016063349

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous fistula extraluminal mesh-sleeveA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600196773
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016063318VasQ1FG00312023-11-26
07290016063325VasQ2FG00322023-11-26
07290016063332VasQ3FG00332023-11-26
07290016063356VasQ5FG00352023-11-26
07290016063363VasQ6FG00362023-11-26
07290016063370VasQ DMST5 unit packFG00372023-11-26
07290016063387VasQ DMST20 Unit packFG00382023-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016063318VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063325VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063332VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063356VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063363VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26