SOLICITATION NOTICE
65 -- NOTICE OF INTENT TO SOLE SOURCE HANDHELD FUNDUS CAMERA TO CLARITY MEDICAL SYSTEMS
- Notice Date
- 2/27/2009
- Notice Type
- Presolicitation
- NAICS
- 339115
— Ophthalmic Goods Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, Maryland, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-09-T-0113
- Archive Date
- 3/19/2009
- Point of Contact
- Christina Boyd-Brown,, Phone: 301-619-2059, Burzie C Baker III,, Phone: 301-619-0707
- E-Mail Address
-
christina.boyd-brown@med.navy.mil, burzie.baker@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Clarity Medical Systems, 5775 West Las Positas Blvd, Pleasanton, CA 94588-4084, as the only responsible source that can provide a portable handheld fundus camera system that is suitable for use on neonates and infants. The requirement is for a handheld fundus camera. The system shall be used to document ophthalmic pathology in the Neonatal Intensive Care Unit (NICU). The system shall be portable and compact to allow for movement within the NICU. The system shall not require the use of sedation to be used on an infant. The image capture technique shall be capable of being performed without cooperation from the patient such as looking where directed or staying still, as would be necessary for neonates or infants. The image capture technique shall also be capable of being preformed by non-ophthalmic medical personnel. The system shall also include an 80º, wide-angle lens to obtain more magnified and detailed images of the optic nerve and discreet retinal lesions suitable for pre-mature infants. Clarity Medical Systems is the only acceptable manufacturer that can provide a handheld fundus camera that meets the requirements of the government. Regulatory Requirements: The system and all of the components 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, even should delivery be requested outside of the United States. 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, even should delivery be requested outside of the United States. This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339115 with a Small Business Size Standard of 500 employees. 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 shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Submit email capability statements (using PDF, MS Word, Excel attachments) to Christina Boyd-Brown at christina.boyd-brown@med.navy.mil. Fax quotes may be sent to 301-619-1132 Attn: Christina Boyd-Brown. Email statements are preferred. Statements are due not later than 4:00 P.M. EST on 04 March 2009. No phone calls accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=33b95dae6772dc0ad30e5c5f9c38e3c1&tab=core&_cview=1)
- Place of Performance
- Address: Naval Medical Logistics Command, 693 Neiman Street, Fort Detrick, Maryland, 21703, United States
- Zip Code: 21703
- Zip Code: 21703
- Record
- SN01758964-W 20090301/090227220617-33b95dae6772dc0ad30e5c5f9c38e3c1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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