6515--691/GLA_CUSTOM IV KIT

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Contract Opportunity

1.The purpose of amendment 0001 to RFQ 36C26226Q0101 is to provide answers to questions from interested parties as well as provide updated specifications.
S05 - Questions and Answers
Question 1: Are you able to please advise if a waiver would be in place for this opportunity or if it would be acceptable to submit our response by providing a copy of our authorized distributor letter from the original equipment manufacturer?
Answer 1: In this case, nonmanufacturer rule waiver is granted and the Limitations of Sub-Contracting Cert/Certificate of Compliance is tailored for the purpose. In addition to completing the previously mentioned document, please also include a copy of the authorized distributor letter from the original equipment manufacturer.

Question 2: Vendor does not carry the requested custom items on FSS contract. Are you able to please advise if this requirement can be removed from this solicitation or if we are still permitted to provide these items via open market for this opportunity?
Answer 2: Yes, you are permitted to provide these items via an open-market opportunity.

Question 3: Is this published RFP for just one year? Or it's asking for pricing of 45,000 kits per year for five years?
Answer 3: This published RFQ is for a one-year contract. A total of 900 cases are required to be delivered over the contract period (12-month period), with seventy-five (75) cases shipped to the hospital monthly. 45,000 refers to the individual quantities of items in each kit for the total contract period / period of one year.

Question 4: What type of package will the kit go into (tray, pouch, etc.)?

Answer 4: A sterile package

Question 5: Do you have packaging specifications, so we know what needs to be sourced?

Answer 5: Packaging must be sterile

Question 6: Does the kit require sterilization? a. If yes, what method (Gamma or Eto)?

Answer 6: The kit is required to be sterile. Gamma or Eto is fine. Please ensure that the sterilization method used is allowable in California.

Question 7: If no sterilization is required, do the components need to be kitted in a cleanroom?

Answer 7: The preference is for the kits to be sterile. If not available, we will consider clean packaging since the item is not used in a sterile field.

Question 8: Are there any cleanroom requirements (e.g., ISO 7 or ISO 8)?

Answer 8: None
Question 9: Any special handling requirements?

Answer 9: Must be boxed

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