MODIFICATION
99 -- Impact Portable Ventilators
- Notice Date
- 3/17/2011
- Notice Type
- Modification/Amendment
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N6264511RC803
- Archive Date
- 3/31/2011
- Point of Contact
- Jaime R. Belletto, Phone: 3016193020
- E-Mail Address
-
jaime.belletto@med.navy.mil
(jaime.belletto@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to solicit and negotiate on a sole source basis under the authority of FAR 13.501 with Impact Instrumentation, 27 FAIRFIELD PL, CALDWELL, NJ 07006. as the only responsible source that can provide a EMV+ Portable Ventilators. USNS Comfort T-AH20 has a requirement for 20 portable ventilators. The unit shall be designed for use on all types of patients ranging from infants (5kg or greater) to adults. The unit shall have a built in compressor, air/oxygen blender with 100% capabilities and SpO2 monitoring capabilities. The unit shall have invasive and noninvasive ventilation options. The unit shall have CPAP (continuous positive airway pressure) with/without pressure support, Pres A/C (pressure control AC mode), Vol A/C (volume control AC), V SIMV (volume synchronized intermittent mechanical ventilation), and P SIMV (pressure synchronized intermittent mechanical ventilation) with/without pressure support mode options available. The unit shall have an internal battery providing approximately 10 hours of power. The unit shall have a real-time battery life indicator, displaying the hour and minute information available for usage, visible on the monitor to avoid power shut downs due to incorrect estimation about when the ventilator will need to be connected to a power source for recharging. An internal battery shall be available with the portable ventilator. The electrical requirements are 100-240 VAC, 50/60Hz, and 12-28VDC. The unit should have a display that shows waveforms settings and alarms. Have alarm indicators visual and audible. Be able to operate in low/ high temperature climates estimation of 13-to +167 degree Fahrenheit. The unit shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America. The unit shall be reviewed and approved by Equipment Program Review Committee per NAVMED P-5132, Article 3-3. The unit shall be compliant with IEC 60601-1, UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-8, and ISO 10651-2. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the Test Program for Certain Commercial Items (section 4202 of the Clinger-Cohen Act of 1996). There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America industry Classification System (NAICS) 334510 with a Small Business Size Standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Jaime Belletto, jaime.belletto@med.navy.mil by 4 PM EST on 31 March 2011. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264511RC803/listing.html)
- Record
- SN02403535-W 20110319/110317234801-d920e74b38943ea1784b9178f736318c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |