3D Printed

Nasopharyngeal Swabs for 

COVID-19 Detection.

Medical TI's COVID-19 initiative has converted our FDA-registered facility for the production of Nasopharyngeal (NP) Swabs for the detection of COVID-19. Our swabs utilize a design, material, and manufacturing process that is both preferred by leading healthcare providers¹ and registered with the FDA² for use in testing for COVID-19. 

Flexible

Our NP swabs can bend over 180° and do not snap or shatter.

FDA Registered

Applicator, Absorbent Tipped, Sterile, Product Code KXG: Link

Applicator, Absorbent Tipped, Non-Sterile, Product Code KXF: Link

Won't Interfere with PCR/Reagents

In testing performed by BIDMC, a spiked sample was used to test performance of the 3D printed swab against a polyester
control swab. The results between the two swabs did not vary

Rapid Shipment

We have reoriented our FDA-registered facility and equipment for the rapid production and shipment of NP swabs.

Autoclavable

In testing, our swabs
continued to perform the same after being sterilized by steam at 270°F at 27 Pa in an autoclave.

Clinician Approved

Beth Israel Deaconess Medical Center (BIDMC), which ran the trial, received positive comments from study staff for comfort, flexibility, and ease of insertion, which we attribute to the use of EnvisionTEC’s E-Guide Soft material.

Specifications

Total Length: 148mm

Neck Diameter: 1mm

Neck Length: 39mm

Handle Diameter: 2.5mm

Handle Breakpoint Diameter: 1.5mm

Head Feature Thickness: 0.4mm

Head Diameter: 3mm

Head Length: 17mm

Material: E-Guide Soft C-29C Resin (Non-cytotoxic, not a sensitizer, non irritating.)

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Resources:

Press Releases:

April 20, 2020 – BIDMC-led clinical trial identifies four novel 3D-printed swabs for use in COVID-19 testing – Link

April 15, 2020 – EnvisionTEC to 3D Print Mass Quantities of Nasopharyngeal Swabs for COVID-19 Testing Based on Successful Clinical Trial – Link

March 29, 2020 – EnvisionTEC Partners With Healthcare Community to Battle Global Pandemic – Link

Clinical Studies:

Preprint of BIDMC manuscript: Link

Miscellaneous:

EnvisionTEC 3D Printed Swabs Description, FAQ, and Specifications: Link

Regulatory:

Medical TI Nasopharyngeal (NP) Swab Regulatory Information:

NP Swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR 880.6025 Absorbent tipped applicator.

Medical TI's NP Swabs have been developed by EnvisionTEC, Inc. with review from Beth Israel Deaconess Medical Center (BIDMC). Our swab designs have unique FDA Device Listing Numbers: D396115 (Sterile) and D397217 (Non-Sterile).

Medical TI Facility Registration Number: 3016772742

 
 
 
 
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