THIS IS A SOURCES SOUGHT NOTICE ONLY: This announcement seeks information from the industry, which will be used for preliminary planning purposes for procurement. No quotes are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR QUOTES AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS. THIS IS STRICTLY MARKET RESEARCH. Medtronic/Coviden Nellcor Portable SpO2 Patient Monitoring System, Model PM10N, brand name or equal, domestic and non-domestic. The purpose of this synopsis is to gain knowledge of interest, capabilities, and qualifications of various members of industry, who have the capability to provide the following items: ITEM NUMBER DESCRIPTION QUANTITY UNIT OF MEASURE 0001 PM10N PORTABLE SpO2 PATIENT MONITOR 34 EA 0002 PMAC10N-G PORTABLE SpO2 COVER GREEN 34 EA 0003 DS100A-1 DURASENSOR ADULT FINGER CLIP 1 BX 0004 DURA-Y SENSOR 34 EA 0005 DURA-Y SENSOR EAR 34 EA All interested firms must be registered in SAM (System for Award Management) to be eligible for the award of Government contracts. Interested parties responding to this Sources Sought request shall submit the following information at a minimum: (1) Company name and address point of contact with phone number and SAM UEI. (2) Documentation relating to performance capability, current point of contact, and phone number). (3) Socio-economic status to identify the business class as a large business, SDVOSB, VOSB, small business, Woman Owned, etc. (4) Place of manufacture (5) Any other pertinent company documentation prior to submission of offers to a solicitation. Any SD/VOSB firms responding to this Sources Sought Notice must also provide proof of registration in the SBA Vet Cert prior to submitting offers to a solicitation. This market research is for informational and planning purposes. This is not a solicitation and does not obligate the Government to issue a solicitation. Please be advised that the government will not pay any costs for responses and information submitted. All submissions are acceptable via
[email protected] RESULTS INFORMATION: Respondents will not be notified of the results, and it is at the discretion of the Government to utilize results. Firms responding to this Sources Sought announcement, who fail to meet all requirements as stated above, and who fail to provide ALL the required information requested, will not be used to help the Government make the acquisition decision, which is the intent of this sources sought announcement. FDA Clearance Must have pre-market approval Stand-Alone / Modular Must be a handheld device Displays Must display Sp02 and heart rate. Signal strength is added value. Display must be backlit and easily visible in the dark. Sp02 Range must be greater than 1-100% Accuracy must be +/- 3%, added value if accuracy is +/- 2% or more accurate. Pulse Rate Range must be greater than 30-240bpm, added value if range is closer to 20-300bpm Accuracy must be +/- 5bpm including with motion. Added value if accuracy is +/- 2bpm or more accurate. Perfusion Index And/Or Signal Strength Indicator Signal strength indicator is added value. Response Time Added value for lower response times Alarms Must be visual and audible Patient alarms must include out-of-range Sp02 and heart rate. Equipment alarms must include low battery and probe disconnection User must be able to control volume and/or silence alarm Self-Test Mode Must offer self-test mode Probe Types Must include reusable adult digit and ear probes Cable length must be greater than 2 ft Dimensions and Weight Must fit comfortably in the user's hand Battery Must have replaceable battery option