Attachment B_Salient Characteristics_Medtronic Brand Name or Equal Generators and Caths.docx

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6515--691 - Medtronic Generator Systems and Catheters
Solicitation number
36C26225Q1198
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The document is a Salient Characteristics specification for the Medtronic Symplicity Spyral Renal Denervation System and associated medical equipment, part of a Department of Veterans Affairs (VA) solicitation for the VA Greater Los Angeles Healthcare System. The solicitation (RFQ 36C26225Q1198) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside procurement seeking a contractor to supply medical devices including the Symplicity G3 Generator, Spyral Catheter, Sherpa and Launcher Guide Catheters, and Valleylab REM Polyhesive Electrodes or equivalent products.

Key procurement details include a 4-month performance period with a 30-day delivery timeframe, with quotes due by July 29, 2025, at 9:00 AM PT. The VA will award a single Firm-Fixed Price contract to the lowest-priced, technically acceptable offeror meeting all salient characteristics. Vendors must provide an authorized distributor letter, specify manufacturer part numbers, confirm compliance with Buy American Act and Trade Agreement Act, provide country of origin, and verify the items are not gray market products. Offerors must demonstrate that any equivalent products meet the detailed technical specifications outlined in the attachment, which include precise electrical, material, and dimensional requirements for the medical equipment.

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36C26225Q1198 0001.docx DOCX document
36C26225Q1198.docx DOCX document
Attachment A_36C26225Q1198_BRAND NAME OR EQUAL_ Medtronic Generators and Caths.xlsx XLSX spreadsheet

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Salient Characteristics Symplicity Spyral Renal Denervation System, Sherpa and Launcher Guide Catheters, Valleylab REM Polyhesive Electronodes, or Equivalent.

- Symplicity G3™ Generator (RDNG3A) or Equivalent.

- Cart For Symplicity G3™ Generator (RDN019) or Equivalent

- Symplicity Spyral™ Catheter (RDN016) or Equivalent

- Sherpa™ NX Balanced 6Fr 55-cm Guide Catheter (SB6RDND1K) or Equivalent

- Sherpa™ NX Balanced 6Fr 55-cm guide Catheter (SB6IMAK) or Equivalent

- Launcher™ 6Fr 55-cm guide catheter (LA6IMAK) or Equivalent

- Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, 9' (2.7 m) or Equivalent (E7507)

- Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, 15' (4.6 m) or Equivalent (E7507DB)

a. Generator

· Painted and nonpainted sheet metal

· Polycarbonate/acrylonitrile butadiene styrene blend (external covers)

· Thermoplastic elastomer (cord management strap)

· Glass (projected capacitance touchscreen)

· Electrical Data

· RF output power 6.5 W maximum per electrode (26 W total)

· ±20% accuracy with impedance of 175 Ω to 200 Ω

· ±10% accuracy with impedance of 201 Ω to 1200 Ω

· Impedance measurement 175 Ω to 250 Ω, ±20%

· 251 Ω to 700 Ω, ±10%

· 701 Ω to 1200 Ω, ±15%

· Fuse 2 Slow-Blow (T3.15A L, 250 V), 20 x 5 mm

· Temperature range Measurement 37 °C to 65 °C, ±3 °C

· Input power 100 to 240 V ~, 50/60 Hz universal power supply, 200 VA input power rating

· Disconnecting the AC power cord removes AC mains power from the unit

· AC power cables NEMA 5-15 3.0 m

· Rated accessory voltage 150 Vp

· Maximum output voltage 150 Vp

· Maximum current rating 700 mA averaged over 60 s

b. Catheters

· Proximal shaft: polyether block amide laminated over stainless steel

· Intermediate tubing: polyether block amide with braided stainless steel

· Distal electrode array jacket: thermoplastic urethane

· Electrodes: 4 RF monopolar, gold, radiopaque

· Tip: thermoplastic

· Tip marker: platinum/iridium alloy

· Guidewire lumen: high-density polyethylene liner

· Spiral shaping element: nickel/titanium

· Guidewire loading tool: thermoplastic

· Handle-ABS, thermoplastic elastomer overmold

· Thermocouple-T-type

· Not present-Latex, Phthalate

File details come from the government source that posted it. Updated .