VasQ
- Primary DI
- 07290016063363
- Brand
- VasQ
- Company
- LAMINATE MEDICAL TECHNOLOGIES LTD
- Model
- 6
- Catalog number
- FG0036
- 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 |
|---|
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN220026 | 000 | VasQ | Laminate Medical Technologies , Ltd. | 2023-09-26 | QVQ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290016063363 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290016063363 | 07290016063363 | 7290016063363 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
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
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