36C79119Q0014-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Commercial Item - Supply Restock of Artificial Larynges and Associated Items (VA-19-00032947) 80401-5621 36C79119Q0014 07-22-2019 N 339113 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621 Star M Yeo 555 Corporate Circle Golden CO 80401

USA

star.yeo@va.gov Star Yeo, Contract Specialist The VA Denver Logistic Center (DLC) intends to issue a Request for Proposals (RFP) for the restocking of Artificial Larynges at the Denver Logistic Center, located in Golden, CO.

The contractor shall minimally provide and deliver an FDA Device Registered (FDA 21 CFR 874.3375) Artificial Larynx that meets or exceeds the technical specifications described below in this section.

Digital Extra-Oral Artificial Larynx Device (B.5.1 CLIN 01) The artificial larynx shall meet the following minimum technical requirements and minimum functions:

I. The device is used to produce speech in the absence of a functioning larynx.

II. The device functions extra-orally by manual placement against neck or cheek surface; and intra-orally by intra-oral tube placement in the oral cavity with use of an oral adaptor and intra-oral tube.

III. When pressed against the skin on the neck or outer cheek sound vibrations are conducted through the neck or cheek tissue into the pharynx and oral/nasal cavities and “shaped” by the articulators (tongue, lips) to produce speech. When the oral adaptor is used, the intra-oral tube transmits sound directly into the oral cavity.

IV. The digital device must be hand-held; battery-operated, capable of working with rechargeable battery/batteries, include a battery charger, and include at least two rechargeable batteries.

V. The device must produce sound and include a manual volume control with a high/low range of volume.

VI. The device must also have a range of pitch/tone settings with an internal and/or external pitch/tone setting adjustment(s).

VII. The device must include an oral adaptor and intra-oral tubes.

VIII. The device must have a manually depressed button that produces sound vibrations.

IX. The device must include a commercial warranty that meets or exceeds one year.

Analog Extra-Oral Artificial Larynx Device (B.5.2 CLIN 02) The artificial larynx shall meet the following minimum technical requirements and minimum functions:

I. The device is used to produce speech in the absence of a functioning larynx.

II. The device functions extra-orally by manual placement against neck or cheek surface; and intra-orally by intra-oral tube placement in the oral cavity with use of an oral adaptor and intra-oral tube.

III. When pressed against the skin on the neck or outer cheek sound vibrations are conducted through the neck or cheek tissue into the pharynx and oral/nasal cavities and “shaped” by the articulators (tongue, lips) to produce speech. When the oral adaptor is used, the intra-oral tube transmits sound directly into the oral cavity.

IV. The analog device must be hand-held; battery-operated, capable of working with rechargeable battery/batteries, include a battery charger, and include at least two rechargeable batteries.

V. The device must produce sound and include a manual volume control with a high/low range of volume.

VI. The device must also have a range of pitch/tone settings with an internal and/or external pitch/tone setting adjustment(s).

VII. The device must include an oral adaptor and intra-oral tubes. The device must have a manually depressed button that produces sound vibrations.

VIII. The device must include a commercial warranty that meets or exceeds one year.

Analog Intra-Oral Artificial Larynx Device (B.5.3 CLIN 03) The artificial larynx shall meet the following minimum technical requirements and minimum functions:

I. The device is used intra-orally to produce speech in the absence of a functioning larynx.

II. The device functions by intra-oral tube placement in the oral cavity. Sound vibration is conducted through a thin tube placed directly into the oral cavity where it can be “shaped” by the articulators (tongue, lips) to produce speech.

III. The analog device is a dedicated intra-oral device and cannot be used by manual placement against the neck or cheek surface.

IV. The analog device must be battery powered, hand-held, and have a manually depressed button that activates sound which is conducted from the device through the intra-oral tube directly into the oral cavity.

V. The device must produce sound and include a manual volume control with a high/low range of volume.

VI. The device must also have a range of pitch/tone settings with an internal and/or external pitch/tone setting adjustment(s).

VII. The device must include at least two batteries.

VIII. The device must include a commercial warranty that meet or exceeds one year.

Digital Intra-Oral Artificial Larynx Device (B.5.4 CLIN 04) The artificial larynx shall meet the following minimum technical requirements and minimum functions:

I. The device is used intra-orally to produce speech in the absence of a functioning larynx.

II. The device functions by intra-oral tube placement in the oral cavity. Sound vibration is conducted through a thin tube placed directly into the oral cavity where it can be “shaped” by the articulators (tongue, lips) to produce speech.

III. The digital device is a dedicated intra-oral device and cannot be used by manual placement against the neck or cheek surface.

IV. The device must be battery powered, hand-held, and have a manually depressed button that activates sound which is conducted from the device through the intra-oral tube directly into the oral cavity.

V. The device must produce sound and include a manual volume control with a high/low range of volume.

VI. The device must also have a range of pitch/tone settings with an internal and/or external pitch/tone setting adjustment(s).

VII. The device must include at least two batteries.

VIII. The device must include a commercial warranty that meets or exceeds one year.

IX. The device is digital.

Eligible vendors shall be FDA Class 1 Device Registered.

Request for Proposals shall be issued on or about July 12, 2019. Please contact Star M. Yeo, Contract Specialist in writing for additional details at star.yeo@va.gov