Device ClassificationMedical Device Directive Conformity Route: MDD 93/42/EEC: ANNEX II

Medical Device Directive Classification and Rule: Class IIa, Rule 7

CE MarkCE 0086

Device DescriptionThe Jelco IntuitIV Safety IV Catheter™ is a sterile, non-pyrogenic, single-use, radiopaque intravascular catheter used for the administration of medically prescribed fluids. This catheter offers passive needle protection as the tip protector automatically engages over the needle tip as the needle is removed from the catheter. The flash chamber provides distinct visibility of blood flashback. The catheter is available in straight hub and sideport hub versions. The Luer taper/Luer lock catheter hub is color-coded based on catheter gauge size requirements of ISO 10555-5 and meets the dimensional requirements of ISO 594-1 and ISO 594-2.

Indications*A properly placed IV catheter provides access to a vein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The straight hub catheters (14 through 24 gauge) may be used with power injec-tors up to 300 psi. Both the straight hub and sideport hub catheters are rated as MR conditional.

Precautions*This device is designed to help reduce the risk of accidental needlesticks. In addition to these in-structions for use, it is recommended that the health care professional follow the recommendations set forth by the CDC and OSHA standards (USA) or local equivalent for bloodborne pathogens when starting, maintaining, or discarding any IV catheter to avoid the risk of exposure to blood.

Follow current institutional policies and procedures for catheter insertion, maintenance and removal.

Manufacturing Site Name and AddressSmiths Medical Italia S.r.L Via, della Stazione 2 04013 Latina Scalo, Latina, Italy

Sterilization MethodSmiths Medical uses a validated sterilization cycle to sterilize this product. Validation and routine operation is performed based upon the guidelines set forth in ISO 11135-1. The sterilant used is Ethylene Oxide (EO). The products are for single-use only and they cannot be resterilized.

Shelf LifeSterile DevicesA 2-year expiration date is assigned to the product as long as the packaging is undamaged and unopened, based on accelerated aging stability shelf life testing.Note: The 14g straight catheters will have an initial shelf life of 1-year.

*Note: Please refer to the Instructions For Use provided with the device for a full listing of the Indications and the Precautions.

Jelco IntuitIV Safety IV Catheter™ Technical Summary Sheet

Straight Hub

Sideport Hub

4

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Straight HubEach Jelco IntuitIV Safety Catheter™ consists of an introducer needle and an integral needle tip-protector. Key parts are: (1) needle bevel, (2) needle, (3) catheter, (4) catheter hub, (5) tip-protector, (6) flash chamber, (7) flash plug assembly, (8) sheath.

Before use: After use:

Sideport HubEach Jelco IntuitIV Safety Catheter™ consists of an introducer needle with an integral tip-protector and a catheter. Key parts are (1) needle bevel, (2) needle, (3) catheter, (4) catheter hub, (5) tip-protector, (6) flash chamber, (7) flash plug assembly, (8) sheath, (9) snap cap, (10) thumb tab, and (11) Luer lock cap.

Before use: After use:

Device Components

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Component Composition• Catheter Tube: Polyurethane (PUR) or fluorinated ethylene propylene (FEP); barium sulfate (for radiopacity)• Eyelet: Stainless steel• Catheter Hub: Polypropylene• Valve (Sideport only): Silicone rubber• Snap Cap (Sideport only): Polypropylene• Tip Protector: Outer Sleeve: Stainless steel Inner Sleeve: Polyoxymethylene (acetal) Bump Stop Washer: Stainless steel

• Needle Hub: Polypropylene • Needle: Stainless steel• Flash Plug: Polyethylene• Flash Plug Filter Paper: Versapor Tipo • Sheath (Straight Only): Polypropylene• Sheath Straw (SidePort Only): Polyethylene• Sheath End Cap (SidePort Only): ABS • Lubricants: Silicone, alcohol (sideport only)

Labeling and PackagingOne (1) catheter unit is packaged per each flexible, peel-open blister. The blister label is color-coded based on catheter gauge size and is printed with product specific information. Product is sterile, non-toxic and non-pyrogenic unless package is open, wet, or damaged.

Discard if open, wet, or damaged. Fifty (50) units are packed per shelf pack, and twelve (12) shelf packs are packed per case. The lot number, manufacturing date and expiration date are located on the right side of the blister, shelf and case pack labels as well.

Container Type Length Width Height Weight

SP Box (50 units) 192mm 175mm 168mm 0.4kg

ST Box (50 units) 141mm 76mm 146mm 0.3kg

SP Case* (600 units) 584mm 360mm 351mm 4.8kg

ST Case* (600 units) 470mm 294mm 165mm 3.6kg

* 600-unit cases available in certain markets

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14 GAUGE

14 GAUGE

20 GAUGE

18 GAUGE

16 GAUGE

22 GAUGE

16 GAUGE

14 GAUGE

20 GAUGE

20 GAUGE

18 GAUGE

24 GAUGE

18 GAUGE

16 GAUGE

20 GAUGE

22 GAUGE

18 GAUGE

Product Gauge X Product Length

Sideport PUR Code

Sideport FEP Code

Flow Rate (mL/min)

Product Gauge X Product Length

Straight PUR Code

Straight FEP Code

Flow Rate (mL/min)

Product Gauge X Product Length

Straight PUR Code

Straight FEP Code

Flow Rate (mL/min)

2.2mm X 45mm

or 14G x 1.75"

7214-INT

7114-INT

340

2.2mm X 32mm

or 14G x 1.25”

7268-INT

7138-INT

355

1.1mm X 25mm

or 20G x 1.0”

7267-INT

7137-INT

68

1.3mm X 32mm

or 18G x 1.25"

7219-INT

7119-INT

100

1.8mm X 32mm

or 16G x 1.25”

7261-INT

7131-INT

225

1.1mm X 45mm

or 20G x 1.75”

7269-INT

7139-INT

60

1.1mm X 32mm

or 20G x 1.25"

7220-INT

7120-INT

65

1.3mm X 32mm

or 18G x 1.25”

7265-INT

7135-INT

110

.07mm X 1.9mm

or 24G x .07”

7263-INT

7133-INT

24

1.8mm X 45mm

or 16G x 1.75"

7216-INT

7116-INT

210

2.2mm X 45mm

or 14G x 1.75”

7288-INT

7188-INT

340

1.1mm X 32mm

or 20G x 1.25”

7266-INT

7136-INT

65

1.3mm X 45mm

or 18G x 1.75"

7218-INT

7118-INT

90

1.8mm X 45mm

or 16G x 1.75”

7262-INT

7132-INT

210

0.9mm X 25mm

or 22G x 1.0”

7260-INT

7130-INT

38

0.9mm X 25mm

22G x 1.0"

7222-INT

7122 INT

35

1.3mm X 45mm

or 18G x 1.75”

7264-INT

7134-INT

100

SIDEPORT FLOW RATES

STRAIGHT FLOW RATES

Jelco IntuitIV Safety IV Catheter™ Product Range and Flow Rates

Smiths Medical ASD, Inc.Southington, CT 06489, USAPhone: 1-860-621-9111Toll-Free USA: 1-800-847-5831www.smiths-medical.com

Smiths Medical is part of the global technology business Smiths Group plc. Product(s) described may not be licensed or available for sale in all countries. Jelco IntuitIV Safety IV Catheter and the Smiths Medical and Jelco design marks are trademarks of Smiths Medical. The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries. There is no connection between Smiths Medical and Intuitive Surgical. ©2013 Smiths Medical. All rights reserved. SS195394GL-052013

Find your localcontact information at:www.smiths-medical.com/customer-support

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