Medical Consumables - Delivery, If Necessary, Of 4 /Four/ Generators For 68Ga For A Period Of 24 Months. Delivery, If Necessary, Of 4 /Four/ Generators For 68Ga For A Period Of 24 Months. Delivery Term - According To The Contractors Technical Proposal, But No More Than 70 /Seventy/ Calendar Days. Order Number / Name / Measure / Estimated Quantity For 24 Months 1 Gallium Generator - Type 1 - Ge-68/Ga-68 Gallium-68 Generator Compatible With Itm Iqs-Ts Fusion Module (Germany) With Activity 50Mci/1850 Mbq, Including: Transport, Installation And Replacement Of Connecting Lines - 1 Piece 2 Hydrochloric Acid Hcl - Sterile Disposable Vials With 0.05M Hcl For Gmp Elution, Compatible With Itm Ge-68/Ga-68 - Vial Volume 4Ml - Vial - 250 3 Gallium Generator - Type 2: Number- 3 1. The Generator Must Comply With Cgmp (Good Manufacturing Practice); 2. Parent Nuclide: Ge68 (Germanium); 3. Daughter Nuclide: Ga68 (Gallium); 4. The Activity Of The Gallium 68 (68Ga) Generator Should Be ≥ 50 Mci; 5. Volume Of Elution Medium - ≤ 5 Ml 6. Molarity Of Elution Medium - ≤ 0.1M Hcl 7. Allowable Endotoxins In The Eluate: ≤ 175 Eu/Ml; 8. Generator Durability - A Minimum Of 250 Elutions Or A Minimum Of Ten Months After Calibration, Whichever Occurs First. 9. The Generator Should Be Delivered With An Elution Medium (Hcl) Sufficient For 250 Elutions 1. The Shelf Life Of The Medical Devices Should Be No Shorter Than 12 (Twelve) Months, Counted From The Date Of The Receipt - Transmission Protocol For Their Delivery; 2. The Participant Must Submit Catalogs, Brochures, Information Sheets Or Equivalent With The Offered Products, In Which There Is Detailed Information About Them With A Translation Into Bulgarian, From Which All The Indicators And Production Characteristics Are Visible, From Which The Quality Of The Offered Product And Its Compliance With The Technical Specifications Can Be Proven In An Indisputable Way. 3. If Necessary, The Requested Quantities Can Be Exceeded. 4. The Participant Must Be Authorized By The Manufacturer Of The Medical Devices Or His Authorized Representative To Sell The Relevant Product On The Territory Of The Republic Of Bulgaria.
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