List of Registered Needleless Systems and Sharps Devices with Engineered Sharps Injury Protection - Medical Device Bloodborne Pathogen Control
Texas Health and Safety Code (HSC) Chapter 81, Communicable Disease; Public Health Disasters; Public Health Emergencies Act, has been amended. HSC Section 81.307, which contained the language requiring the department to maintain a list of registered needleless systems and sharps with engineered sharps protection was repealed by Senate Bill (SB) 970, passed during the 87th Texas Legislature, Regular Session. Many of the other parts of HSC Chapter 81, Communicable Disease; Public Health Disasters; Public Health Emergencies Act were not repealed. The department will no longer accept applications for registration of needleless system devices or a sharps device with engineered sharps injury protection.
NOTE: The inclusion of a registered device on this list shall in no way represent or imply an endorsement or recommendation of any such device by the Texas Department of State Health Services.
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Product Name |
Unistik 2, Unistik 3 |
|---|---|
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Model Name and/or Number: |
Normal, Extra, Super, Comfort, Dual |
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DSHS Registration Number: |
0046595-DV00004 |
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Sizes Available: |
18g, 21g, 23g, 28g |
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Common Name/Type: |
blood lancet/single-use safety lancet |
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Needleless System or Sharps Device: |
Sharps |
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If a Sharps Device, Physical Safety Attributes: |
Withdrawal/Retraction |
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How Safety Feature is Activated: |
Push in the lancet until it clicks. Twist off the cap. Press the firing pad. The lancet then automatically retracts reducing risk of needlestick. |
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Product Description: |
Unistik is a simple, safe and self contained single use lancet. There are no endcaps, lancets or complex devices to assemble, making for easy usage. All needles for the Unistik are aseptically protected until use. Because Unistik is single use, there is no worry of cross infection. All that is needed for use is to push in the lancet, twist off the cap and press the firing pad. The needle retracts. |
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Manufacturer's Information: |
Owen Mumford |