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Addendum 2,1K101026 5 - accessdata fda

Addendum 2,1K101026 5 - accessdata fda 2025

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The document is an addendum for the 510(k) premarket notification submitted by Vidacare Corporation for the Powered PD-10 Intraosseous Infusion System and EZ-IO Humeral Head. It outlines the devices' intended use for providing intraosseous access in pediatric patients during emergent situations when intravenous access is not feasible. The submission claims substantial equivalence to previously cleared devices, indicating no changes in design or technology. The document includes regulatory details, contact information, and a summary of indications for use.

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What is the structure of Zunveyl?

The structural formula for benzgalantamine gluconate is: ZUNVEYL contains 5 mg, 10 mg, 15 mg benzgalantamine equivalent to 7.49 mg, 14.98 mg, and 22.47 mg benzgalantamine gluconate, respectively. ZUNVEYL delayed-release tablets are for oral use.

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Warnings Precautions Allergies to Ingredients. People who are allergic to any of the following should not use Zepbound. Thyroid Cancer or Endocrine Condition. Suicidal Thoughts or Suicide Attempts. Pregnancy. Severe Stomach Problems. Diabetic Retinopathy. Stomach Problems. Pancreatitis.

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Who should not use Zepbound? Allergies to Ingredients. People who are allergic to any of the following should not use Zepbound. Thyroid Cancer or Endocrine Condition. Suicidal Thoughts or Suicide Attempts. Pregnancy. Severe Stomach Problems. Diabetic Retinopathy. Stomach Problems. Pancreatitis.

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Which drugs have a black box warning? Drug classDrug name Antiarrhythmic Pacerone (amiodarone) Antimalarials Mefloquine Monoclonal antibodies Tysabri (natalizumab) Opioids Oxycontin (oxycodone) MS Contin (morphine sulfate) Hydrocodone Fentanyl11 more rows

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Addendum 2,1K101026 5 - accessdata fda 2025

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