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3.1 Do you manufacture and/or distribute Acupuncture Needles, Auricular Press Acupuncture Needles and Semi-Permanent Auricular Acupuncture Needles?
Acupuncture Needles
3.2 Are your Acupuncture Needles manufactured in a Trade Agreement Act (TAA) compliant country? Please identify the country of origin.
3.3 Are your Acupuncture Needles manufactured without natural rubber latex?
3.4 Are your Acupuncture Needles compliant with the special controls listed within CFR Title 21, Volume 8 section 880.5580?
3.5 Are your Acupuncture Needles manufactured and labeled as a single use item?
3.6 Are your Acupuncture Needles manufactured and labeled as a sterile item?
3.7 Are your Acupuncture Needles manufactured in compliance with Good Manufacturing Practice (GMP) guidelines?
3.8 Are your Acupuncture Needles manufactured in compliance with AAMI guidelines?
3.9 Are your Acupuncture Needles manufactured in compliance with International Organization for Standardization (ISO) 9002 standard?
3.10 Are your Acupuncture Needles manufactured in compliance with World Health Organization (WHO) guidelines?
3.11 Are your Acupuncture Needles length and diameter identified on the product packaging?
3.12 Are your Acupuncture Needles packaged with a guide tube?
3.13 Can you provide Acupuncture Needles manufactured with a handle made of plastic?
3.13.1 Are your plastic handled Acupuncture Needles available in diameter of 0.10 mm with length of 15 mm?
3.13.2 Are your plastic handled Acupuncture Needles available in diameter of 0.12 mm with lengths of 15 mm, 30 mm, and 40 mm?
3.13.3 Are your plastic handled Acupuncture Needles available in diameter of 0.14 mm with lengths of 15 mm, 30 mm, and 40 mm?
3.13.4 Are your plastic handled Acupuncture Needles available in diameter of 0.16 mm with lengths of 15 mm, 30 mm, and 40 mm?
3.13.5 Are your plastic handled Acupuncture Needles available in diameter of 0.18 mm with lengths of 15 mm, 30 mm, and 40 mm?
3.13.6 Are your plastic handled Acupuncture Needles available in diameter of 0.20 mm with lengths of 30 mm, 40 mm, and 50 mm?
3.13.7 Are your plastic handled Acupuncture Needles available in diameter of 0.23 mm with lengths of 30 mm, 40 mm, and 50 mm?
3.13.8 Are your plastic handled Acupuncture Needles available in diameter of 0.25 mm with lengths of 30 mm, 40 mm, 50 mm, and 60 mm?
3.13.9 Are your plastic handled Acupuncture Needles available in diameter of 0.30 mm with lengths of 30 mm, 40 mm, 50 mm, and 60 mm?
3.14 Can you provide Acupuncture Needles manufactured with a metal spring type handle?
3.14.1 Are your metal spring type handled Acupuncture Needles available in diameter of 0.20 mm with lengths of 30 mm and 40 mm?
3.14.2 Are your metal spring type handled Acupuncture Needles available in diameter of 0.23 mm with lengths of 30 mm and 40 mm?
3.14.3 Are your metal spring type handled Acupuncture Needles available in diameter of 0.25 mm with lengths of 30 mm, 40 mm, and 60 mm?
3.14.4 Are your metal spring type handled Acupuncture Needles available in diameter of 0.30 mm with length of 60 mm?
Auricular Press Acupuncture Needles
3.15 Are your Auricular Press Acupuncture Needles manufactured in a TAA compliant country? Please identify the country of origin.
3.16 Are your Auricular Press Acupuncture Needles manufactured without natural rubber latex?
3.17 Are your Auricular Press Acupuncture Needles manufactured with hypoallergenic adhesive tape?
3.18 Are your Auricular Press Acupuncture Needles manufactured with a gauge of 0.20 mm?
3.19 Are your Auricular Press Acupuncture Needles manufactured with lengths of 0.3 mm, 0.6 mm, 0.9 mm, 1.2 mm, and 1.5 mm?
3.20 Are your Auricular Press Acupuncture Needles manufactured so that each length is associated with its own distinct color (color coded based on length)?
Semi-Permanent Auricular Acupuncture Needles
3.21 Are your Semi-Permanent Auricular Acupuncture Needles manufactured in a TAA compliant country? Please identify the country of origin.
3.22 Are your Semi-Permanent Auricular Acupuncture Needles manufactured without natural rubber latex?
3.23 Are your Semi-Permanent Auricular Acupuncture Needles manufactured in stainless steel?
3.24 Are your Semi-Permanent Auricular Acupuncture Needles manufactured in gold/gold film coating?
3.25 Are your Semi-Permanent Auricular Acupuncture Needles distributed with an application tube with magnetic tablet?
3.26 Are your Semi-Permanent Auricular Acupuncture Needles distributed with a needle injector with guide and plunger?
4. Feedback Requested
Please complete the attached RFI Vendor Response Worksheet with indicated information about your Acupuncture Needles.
4.1 Have your Acupuncture Needles been subject to any recall(s)? If so, what corrective actions and/or product modifications have been made in response to the recall(s)?
4.2 Do you have any emerging Acupuncture Needle technology you would like to share?
4.3 Please provide any additional information including relative topics outside of the specific information requested which you consider relevant.
Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. All information, comments, and suggestions may be incorporated into future acquisition documents, without identifying the source or obtaining prior approval from the source.
5. Liability
The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI.
6. RFI Responses
6.1 Vendor responses to this RFI must be received by this office no later than 1700 (CST) on 08 December 2017.
6.2 Supporting documentation is required to be provided by the offeror as attachments to this RFI. The RFI Vendor Response Worksheet must be completely filled out and submitted timely along with all supporting material such as but not limited to product catalogs, sale sheets, Training Literature, FDA approval documentation and information, etc.
6.3 Responses and/or questions to this RFI must be submitted via e-mail to the points of contact listed below (para 7). E-mail responses should be no larger than 5 megabytes (MB) in size. If larger attachments are required, additional methods to submit responses include:
6.3.1 Sending documents separately due to size restrictions, as long as each e-mail indicates how many total e-mails are being sent.
6.3.2 The following website can be used for file transfer: AMRDEC safe site file transfer: https://safe.amrdec.army.mil/safe/
6.4 The vendors' responses shall include all detailed information requested in the RFI Vendor Response Worksheet and shall also include: (1) Company name and address; (2) Company POC (Name and Phone Number, Fax Number, and E-mail address); (3) Company website information; and (4) the Company's Commercial and Government Entity (CAGE) Code. Each RFI response will receive a confirmation e-mail.
6.5 Vendor questions regarding this RFI are due no later than 1700 (CST) on 06 December 2017.
7. Points of Contact (POCs):
Mr. Dave Sheaffer, MMESO South Team Leader, [email protected], 210-536-6075 and Mr. Joe Winter, MMESO South Clinical Analyst, [email protected], 210-536-6072.