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Valvuloplasty Pack (TAVI) - NL2


BRIEF DESCRIPTION

Intervantional cardiology pack designed for TAVI procedures

PRODUCT CODE

05-119992AA-03

COUNTRY OF ORIGIN

The Netherlands

TRADE NAME

PACK CARDIO TAVI NL2

APPROVAL BY THE NATIONAL ORGANIZATION FOR MEDICINES (NOM)

2820013138761

PACK CARDIO TAVI NL 2 is a complete, high quality interventional cardiology procedure pack designed to meet the needs of the catheterization (cath) laboratory during TAVI procedures.

It is a ready to use solution that includes all essential medical consumables for TAVI procedures, contributing to reduced preparation time while maintaining full sterility throughout the process.

It is manufactured using high quality materials, sourced only from certified suppliers in the USA, the United Kingdom, and Europe. Final assembly and packaging take place in the Netherlands by Medica Europe B.V., in compliance with strict quality standards and the European Regulation EU 2017/745 (MDR).


Package Contents

PACK CARDIO TAVI NL2 is a complete TAVI procedure set that includes the following components:

S/N

DESCRIPTION

UNIT

1

DRAPE FEM 3PLY radiographic table drape with 2 openings for femoral access and transparent along both sides 380X220cm, Blue

1

2

Surgical Table Cover 195 Χ 150cm, (waterproof, lined, absorbent), Blue

1

3

Transparent protective cover 102 Χ 50cm, round

1

4

Transparent protective cover 91 Χ 104cm, square

1

5

Medical gown size: L, lined and hypoallergenic

1

6

Medical gown size: XL, lined and hypoallergenic

2

7

Hand towel 42.5 X 30.5cm

3

8

10x10cm Gauze, 12ply

50

9

Round Bowl 250ml, Blue

1

10

Round Bowl 500ml, Blue

2

11

Kidney Bowl 700ml, Blue

1

12

Basin 28 Χ 25 Χ 5cm, Blue

1

13

Sharps holder

1

14

3-way, right (multi-tap) manifold, with handles, off, (RA, 600 PSI)

2

15

3-way stopcock 1200 psi (OFF, RA)

1

16

PVC pressure connector 150cm, male/female

2

17

Infusion device with drip chamber

2

18

PVC high pressure connector 30cm, male/female

1

19

2ml Syringe, Luer slip

1

20

10ml Syringe, Luer slip

10

21

20ml Syringe, Luer slip

7

22

12ml coronary angiography syringe (thumb ring, finger rings) with stopper and rotating luer lock adapter (Socorex type)

2

23

Needle 16GX4, white

1

24

Scalpel #11

1

25

Special sponge with plastic handle 15cm, for Betadine of foerster clamp type

1


Key Benefits

  • CE MDR Compliance: Class IIa medical device in accordance with EU Regulation 2017/745
  • Complete set: All necessary components in a single, integrated package
  • Reduced preparation time: Ready to use solution for faster and more efficient setup
  • Consistent high quality: Carefully selected consumables from internationally certified suppliers
  • Optimized logistics: Simplifies inventory and procurement management
  • Full traceability: LOT and Reference Number indicated on each package

Certifications & Packaging

The product is supplied:

  • Sterile
  • Single-use

and complies with the following standards:

  • ISO 13485:2016
  • EN ISO 13485:2016
  • CE marking in accordance with EU Regulation 2017/745 (MDR)
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