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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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EQUATE All-Purpose First Aid Kit, 140 PCBANDAGES: 36-ANTIBACTERIAL SHEER BANDAGES 3/4 IN X 3 IN (1.91 cm x 7.62 cm), 26- ANTIBACTERIAL SHEER BANDAGES 5/8 IN X 2 1/4 IN (1.59 cm x 5.72 cm), 12- ANTIBACTERIAL WATERPROOF BANDAGES 3/4 IN X 3 IN (1.91 cm x 7.62 cm), 5- BUTTERFLY CLOSURES, 4- ANTIBACTERIAL FABRIC BANDAGES 2 IN X 4 IN (5.08 cm x 10.16 cm), 3- ANTIBACTERIAL FABRIC KNUCKLE BANDAGES 1 1/2 IN x 3 IN (3.81 cm x 7.62 cm) (products of China) MEDICINE AND TOPICALS: 12- ALCOHOL PREP PADS (product of China), 8- NON-ASPIRIN TABLETS 4 PACKS (product of China, packaged in the USA), 6- ANTISEPTIC WIPES (product of China), 2- ANTIBIOTIC OINTMENTS 0.03 oz. (0.90 g) (Made in the USA with domestic and imported ingredients), 2- BURN CREAMS 0.03 oz. (0.90 g) (Made in the USA with domestic and imported ingredients) WOUND DRESSINGS: 6- STERILE GAUZE PADS 2 IN X 2 IN/12 PLY (5.08 cm x 5.08 cm), 3- STERILE NON-ADHERENT PADS 2 IN X 3 IN (5.08 cm x 7.62 cm), 2- STERILE GAUZE PADS 4 IN X 4 IN/12 PLY (10.16 cm x 10.16 cm) (products of China) INSTRUMENTS: 5- COTTON-TIPPED APPLICATORS, 2- WOODEN FINGER SPLINTS, 2- EXAMINATION GLOVES 1 PAIR, 1- INSTANT COLD COMPRESS 5 IN X 6 IN (12.70cm x 15.24cm), 1- METAL TWEEZER 3IN (7.62cm), 1- PAPER TAPE 1 IN X 180 IN (5 yd.) (2.54 cm x 4.57 m), 1- FIRST AID GUIDE (products of China) 1- CARRYING CASE (product of China)
WAL-MART STORES, INC.
674041451
In Commercial Distribution

  • 00194346391288 ()
16WAL01375REV2

  • First aid kit, medicated
The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Cinch-Up™ Sun Care Kit Item#3541 Features: Constructed of 190T nylon Push-button adjustable cord clasp Includes 4 latex-free bandages, 2 sunscreen packets, 1 antiseptic towelette, 1 first aid cream packet and 1 Blistex packet
EVANS MANUFACTURING, INC.
3541
In Commercial Distribution

  • G40935410 ()
3541

  • First aid kit, medicated
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-1
In Commercial Distribution

  • 08800076700734 ()
COVAGHT2-U-01

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002783 ()
  • 00895160002786 ()
  • 20895160002780 ()
MD-8147-20T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103420277 ()
10-800-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system
The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
MESA BIOTECH, INC.
COV4100
In Commercial Distribution

  • B540COV41000 ()
COV4100

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-20T
In Commercial Distribution

  • 00855402007979 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-5T
In Commercial Distribution

  • 00855402007962 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-2T
In Commercial Distribution

  • 00855402007955 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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