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Category: I.C.U. Equipment


Performance Parameters

Conforming standards for the I V CanullaIS / ISO 10555-5
Whether IV Canulla is with safety features for preventing needle stick injuriesYes
Flowrate of inside Catheter in ml/min as per IS/ISO 10555-5NA
Needle Point FinishShort bevel cut
Needle HubComplying with ISO 594-1
Needle hub fitting with 6% luer TaperYes
Injection PortWith
Luer Lock Plug/CapYes
Radio opaque line featureYes
Shelf Life (years)3
Removable Vent FittingYes
Non-Toxic and Non-PyrogenicYes
Provision for Recalling productyes

Dimensional And Material Parameters

Material of NeedleStainless Steel Complying with ISO 9626
Material of CatheterVialon biomaterial
Nominal outside Diameter of catheter tube and color coding as per IS/ISO 10555-5Pink – 20G
Effective Length of Catheter Tube in mm as per IS/ISO 10555-5NA


Type of packingblister packing
Packing as per specification and provision of Drug & cosmetic act.yes
All supplies shall have a remaining self life at least five by six (5/6) of the stipulated shelf life at the time of delieveryyes


Availability of valid drug licenceyes
Drug License no & Date of manufacturers and in case of resller, Drug License no & Date (for sale) of Authorized reseller also to be indicatedMFG DL NO. 05/SC/P of 2008 & reseller DL NO.20B/18762,21B/18763 DT.01/10/15
Manufacturers and the Seller must not be under Conviction in terms of provisions of Drug and Cosmetic actyes
Availability of Latest non conviction certificate issued by concerned Drug authoritiesyes
Availability of Certificate for Manufacturing such as GMP under revised Schedule-`M’ of Drugs & Cosmetics Act 1940 Or WHO-GMP or COPP for imports.yes
Details of above Mentioned Certificate such as Type of certificate, Number, date and validityUSC/GMP/115, DT-10/06/17 upto 09/06/19
Availability of any other certification such as CE/FDA/CSA/PQS /ISO etc…Yes
Details of the above mentioned such as Type of certificate, number, date and validity, if Yes otherwise indicate NAISO 13485:2016, No. 180038SJ ,DT-08/06/18 upto 08/06/21
Copies of batch in house Test report to be forwarded with each supplyyes
Copies of certificates to be provided to buyer on demand after placement of orderyes


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