Frequently Asked Questions
Who can buy from NextGen?
Only licensed healthcare providers and clinics. We don't sell to patients or the public.
Do you provide patient care?
No. NextGen Medical Solutions is a medical distribution company and does not provide direct patient care. All treatment decisions are made by licensed healthcare professionals.
What products do you carry?
We supply products in three wound-care categories (amniotic and placental products (HCT/P), wound-care devices cleared through 510(k), and noncontact ultrasound for wound cleansing) and can source other products on request, including imaging and oxygen therapy, and products your clinic already uses. We provide the manufacturer's labeling for any product we supply.
Which brands and manufacturers do you carry?
We share specific products, manufacturers, sizes and pricing with licensed providers once we understand what your practice uses. Contact our team or call (702) 490-9568.
Where do you ship?
We drop-ship nationwide, directly to your clinic address.
Are your products "FDA approved"?
We do not describe any product we carry as 'FDA approved.' FDA approval applies to products that go through premarket approval (PMA) or drug or biologic licensing. Our products are regulated under different FDA pathways:
FDA 510(k)-cleared medical devices: this includes the wound-care devices and the noncontact ultrasound system we carry. FDA cleared each device through the 510(k) premarket notification pathway, finding it substantially equivalent to a legally marketed device for its labeled indications. FDA clearance is not FDA approval.
HCT/P products: regulated under 21 CFR Part 1271. See each manufacturer's IFU for the product's regulatory information.
Imaging and oxygen therapy: regulatory status depends on the specific device. We provide the manufacturer's labeling and FDA status for any device we source.
Ask our team for a specific product's regulatory information.
Can I get the manufacturer IFU?
Yes. We send the manufacturer's labeling (IFU or product sheet) on request for products we supply.
How do I get pricing?
We provide pricing to licensed providers once your account is set up. Use our contact form or call (702) 490-9568.
Can you help with coverage questions?
We answer product-specific coverage questions. Coverage depends on the patient, the plan and medical necessity, and we can't guarantee payment. Coding and billing are the provider's responsibility; coverage varies by payer. We can't tell you whether a specific patient, claim or plan will cover a product.
Do you do coding, billing or claims for clinics?
No. Medical necessity, documentation, coding and billing stay with your practice and your billing team.
Can you recommend a product for a specific patient?
No. Clinical decisions belong to the treating provider. We can share the manufacturer's labeling and answer questions about it, but we don't advise on uses outside that labeling.
Can I send patient information through your website or email?
Please don't. Our website forms and general email aren't meant for patient information. Share only practice and product details.
Who can buy from NextGen?
Only licensed healthcare providers and clinics. We don't sell to patients or the public.
​
Do you provide patient care?
No. NextGen Medical Solutions is a medical distribution company and does not provide direct patient care. All treatment decisions are made by licensed healthcare professionals.
​
What products do you carry?
We supply products in three wound-care categories (amniotic and placental products (HCT/P), wound-care devices cleared through 510(k), and noncontact ultrasound for wound cleansing) and can source other products on request, including imaging and oxygen therapy, and products your clinic already uses. We provide the manufacturer's labeling for any product we supply.
​
Which brands and manufacturers do you carry?
We share specific products, manufacturers, sizes and pricing with licensed providers once we understand what your practice uses. Contact our team or call (702) 490-9568.
​
Where do you ship?
We drop-ship nationwide, directly to your clinic address.
​
Are your products "FDA approved"?
We do not describe any product we carry as 'FDA approved.' FDA approval applies to products that go through premarket approval (PMA) or drug or biologic licensing. Our products are regulated under different FDA pathways:
FDA 510(k)-cleared medical devices: this includes the wound-care devices and the noncontact ultrasound system we carry. FDA cleared each device through the 510(k) premarket notification pathway, finding it substantially equivalent to a legally marketed device for its labeled indications. FDA clearance is not FDA approval.
HCT/P products: regulated under 21 CFR Part 1271. See each manufacturer's IFU for the product's regulatory information.
Imaging and oxygen therapy: regulatory status depends on the specific device. We provide the manufacturer's labeling and FDA status for any device we source.
Ask our team for a specific product's regulatory information.
​
Can I get the manufacturer IFU?
Yes. We send the manufacturer's labeling (IFU or product sheet) on request for products we supply.
​
How do I get pricing?
We provide pricing to licensed providers once your account is set up. Use our contact form or call (702) 490-9568.
​
Can you help with coverage questions?
We answer product-specific coverage questions. Coverage depends on the patient, the plan and medical necessity, and we can't guarantee payment. Coding and billing are the provider's responsibility; coverage varies by payer. We can't tell you whether a specific patient, claim or plan will cover a product.
​
Do you do coding, billing or claims for clinics?
No. Medical necessity, documentation, coding and billing stay with your practice and your billing team.
​
Can you recommend a product for a specific patient?
No. Clinical decisions belong to the treating provider. We can share the manufacturer's labeling and answer questions about it, but we don't advise on uses outside that labeling.
​
Can I send patient information through your website or email?
Please don't. Our website forms and general email aren't meant for patient information. Share only practice and product details.