Disposable Syringes

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Category: I.C.U. Equipment

Description

Performance Parameters

Type of Syringe Sterile hypodermic syringe for single use with needle
Design,material,minimum safety requirements,tolerance and capacity of Syringes confirming to Indian Standard IS 10258-2002 latest for Sterile Hypodermic Syringe for single use with and without needle
Nominal capacity of Syringe(ml) 3
BIS Marking No
BIS Licence No (if BIS Marked if not indicate NA) NA
Design,material,minimum safety requirements,tolerance and capacity of Needles confirming to Indian Standard IS 10654:2002 latest for sterile hypodermic needles for single use
Sterile Yes
No of users Single(Disposable)
Syringe type based on Number of pieces 3 piece
Shelf life (Year(s)) 5

DIMENSIONAL & MATERIAL PARAMETERS

Material of Barrel Polypropylene
Material of Plunger Polypropylene
Material of gasket (For 3 piece) Synthetic rubber
Material of Needle Tube (As per ISO 9626) Stainless Steel

PACKING

Packing as per specification and provision of Drug & cosmetic act. Yes
All supplies shall have a remaining self life of at least Five -Sixth (5/6rd) of the stipulated shelf life at the time of delivery Yes
Type of packing Ribbon Packing
Recalling of Product Yes

Certification And Reports

Availability of valid drug licence Yes
Drug License no & Date of manufacturers and incase of resller, Drug License no & Date (for sale) of Authorized reseller also to be indicated MFR-BR-60(N)AL/12 DATE 05/12/2022, RESELLER, W(1225)/13/W DATED 31/10/13 TO 30/10/18
Manufacturer or the seller must not be under conviction in terms of provision of drug and cosmetic act Yes
Availablitiy 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 GMP Memo No. 15/Au 8-42/12 921(15)H Dated 13/10/17
Availability of any other certification such as CE/FDA/CSA/PQS / ISOetc… No
Details of above Mentioned Certificate such as Type of certificate, Number , date and validity if Yes Otherwise put NA NA
Copies of batch in house Test report to be forwarded with each supply Yes
Copies of certificates to be provided to buyer on demand at the time of supplies Yes

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