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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