Neox® 1K is a cryopreserved ultra-thick amniotic membrane allograft derived from umbilical cord, used for the management of non-healing and chronic wounds.
• Supports a regenerative healing environment to help expedite healing in complex and chronic wounds
Neox® 1K can be used as a wound covering to create a protective environment for wound healing to occur.
Neox® 1K Wound Allograft should not be used on wounds that are actively infected.
Do not use Neox® 1K if the packaging is damaged – Contact BioTissue immediately if there is any abnormality observed (e.g., labeling, packaging, shipping, missing information, etc.). Refer to the Customer Feedback section for reporting.
Neox® 1K exposed to controlled room temperature (20°C to 25°C, 68°F to 77°F) for up to 6 hours may be returned to cold temperature storage in accordance with the Storage section as long as the packaging remains unopened and intact.
Once the outer foil pouch is opened, Neox® 1K shall either be transplanted or otherwise discarded.
Do not sterilize or autoclave the product before use.
Do not use on patients with a history of drug reactions to Amphotericin B, Glycerol, and/or Lactated Ringer's (LR).
As with the use of any human tissue, the possibility of infectious agent transmission cannot be completely eliminated although all screening and microbial testing results for this donor were satisfactory for transplantation.
It is imperative that the graft is stored properly until use. For proper storage instructions, refer to the Storage section.
It is the responsibility of the Tissue Dispensing Service, Tissue Distribution Intermediary, and/or End-User Clinician to maintain tissue intended for transplantation in appropriate storage conditions prior to further distribution or transplant. Upon receipt, ensure the validated time on the shipper has not expired. Remove the product and store accordingly until use.
Location and Temperature: -80°C → 4°C (-112°F → 39.2°F) Example: ultra-low temperature freezer, standard freezer, or standard refrigerator.
Use After Receipt: Within the expiration date printed on product packaging (shelf-life is 2 years from date of manufacture).
Non/Minimally Exudating Wounds
Change Neox® 1K Wound Allograft per facility protocol as needed.
Refer to Neox® Product Application Guide.
HCT/P human amniotic membrane.
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