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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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PRO1TEK 2+ Patient Specialty IFAK Kit - Contains Bleeding Control tools with the addition of a Hemostatic Dressing and other Trauma Kit and First-Aid Equipment.
Pro1tek
B283PTOXFIFAK010
In Commercial Distribution

  • B283PTOXFIFAK010 ()


  • First aid kit, medicated
First aid kit in a plastic cabinet with SmartCompliance boxes. Kit designed for food industry and contains first aid supplies to treat minor injuries.
Acme United Corporation
91095
In Commercial Distribution

  • 00092265910958 ()
91095

  • First aid kit, medicated
Pro Care™ First Aid Kit Item#3555 Features: Deluxe plastic case Includes 15 latex-free bandages, 5 snip bandages, 3 antiseptic towelettes, 3 first aid cream packets, 2 - 2" x 3" adhesive pads, 2 knuckle bandages, 2 non-adherent sterile pads, a gauze roll, an adhesive tape roll and a first aid guide
EVANS MANUFACTURING, INC.
3555
In Commercial Distribution

  • G40935550 ()
3555

  • First aid kit, medicated
First Aid Kit in a Plastic Cabinet with SmartCompliance boxes. Kit designed for food service industry, contains first aid supplies to help treat minor injuries.
Acme United Corporation
91094
In Commercial Distribution

  • 00092265910941 ()
91094

  • First aid kit, medicated
A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 Actuator
In Commercial Distribution

  • 07290103420123 ()
10-200-0002

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator
The XENOVIEW™ Dose Delivery Bag is used to collect the dispensed XENOVIEW™ (xenon Xe 129 hyperpolarized) from the HPX Hyperpolarizer for patient administration. The bag is equipped with a clamp to secure XENOVIEW™ inside, and a mouthpiece for the patient to inhale the gas. XENOVIEW™ Dose Delivery Bags come packaged with 50 one-liter dose delivery bag assemblies, as well as 55 individual bag labels. The XENOVIEW™ Dose Delivery Bag is a single-dose disposable drug container, for use with the HPX Hyperpolarization System.
Polarean, Inc.
Rev B
In Commercial Distribution

  • 00850045949013 ()
44639-01

  • Lung MRI xenon hyperpolarization system delivery bag/mouthpiece
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
Essential Care PEVA Event Kit Item#3529 Features: Reusable and washable PEVA pouch Features a Ziplock closure on top Contents include: 5 latex-free bandages, 3 snip bandages, 2 first aid cream packets, 2 sunscreen packets, 2 paws antimicrobial wipes, 2 lip balm packets, 1 hand lotion, 1- 2” x 3” adhesive pads, and a antacid packet
EVANS MANUFACTURING, INC.
3529
In Commercial Distribution

  • G40935290 ()
3529

  • First aid kit, medicated
No Description
WatMIND USA
RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 10810172700090 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 10810172700083 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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