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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution

  • 00860002028095 ()


  • Oral/upper respiratory tract specimen collection kit IVD, home-use
CaringHands™ Essentials Kit Item#3695 Features: Reusable case is constructed of ripstop material Features a roll top dry sack style design Black buckle closure with carabiner attachment Includes 3 latex-free bandages, 2 knuckle bandages, 3 antiseptic towelettes, 3 lip balm packets, 3 hand sanitizer packets (66.5% Ethyl Alcohol), 3 hand lotion packets and 2 antacid packets
EVANS MANUFACTURING, INC.
3695
In Commercial Distribution

  • G40936950 ()
3695

  • First aid kit, medicated
Emergency Preparedness First Aid Kit Item#3557 Features: Vinyl case with zipper Includes a 12-hour safety light stick, 10 latex-free bandages, 5 snip bandages, two 2" x 3" adhesive pads, 2 knuckle bandages, 5 antiseptic towelettes, 5 first aid cream packets, 2 non-adhesive pads, 1 gauze roll, 1 roll of adhesive tape, and 1 first aid guide
EVANS MANUFACTURING, INC.
3557
In Commercial Distribution

  • G40935570 ()
3557

  • First aid kit, medicated
Primary Care™ Non-Woven First Aid Kit Item#3521 Features: 3" x 5" pouch constructed of 80 GSM non-woven polypropylene Features an aluminum carabiner - Available in Black or Silver Includes 4 latex-free bandages, 2 snip bandages, 2 antiseptic towelettes, a 2" x 3" adhesive pad, a first aid cream packet and a 200 mg Ibuprofen packet
EVANS MANUFACTURING, INC.
3521
In Commercial Distribution

  • G40935210 ()
3521

  • First aid kit, medicated
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031821198 ()


  • Custom-made dental crown, metal/ceramic
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820085 ()


  • Custom-made dental crown, metal/ceramic
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820078 ()


  • Custom-made dental crown, metal/ceramic
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820061 ()


  • Custom-made dental crown, metal/ceramic
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820054 ()


  • Custom-made dental crown, metal/ceramic
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820023 ()


  • Custom-made dental crown, metal/ceramic
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