INTRAVENOUS CANNULAS

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Category: I.C.U. Equipment

Description

Performance Parameters

Conforming standards for the I V Canulla IS / ISO 10555-5
Whether IV Canulla is with safety features for preventing needle stick injuries Yes
Flowrate of inside Catheter in ml/min as per IS/ISO 10555-5 NA
Needle Point Finish Short bevel cut
Needle Hub Complying with ISO 594-1
Needle hub fitting with 6% luer Taper Yes
Injection Port With
Wings With
Luer Lock Plug/Cap Yes
Disposable Yes
Radio opaque line feature Yes
Shelf Life (years) 3
Removable Vent Fitting Yes
Sterile Yes
Non-Toxic and Non-Pyrogenic Yes
Provision for Recalling product yes

Dimensional And Material Parameters

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

PACKING PARAMETERS

Type of packing blister 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 delievery yes

CERTIFICATE AND REPORTS

Availability of valid drug licence yes
Drug License no & Date of manufacturers and in case of resller, Drug License no & Date (for sale) of Authorized reseller also to be indicated MFG 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 act yes
Availability of Latest non conviction certificate issued by concerned Drug authorities yes
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 validity USC/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 NA ISO 13485:2016, No. 180038SJ ,DT-08/06/18 upto 08/06/21
Copies of batch in house Test report to be forwarded with each supply yes
Copies of certificates to be provided to buyer on demand after placement of order yes

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