Page 8 - Fluid Flow - Amnio Hensler 6_2020

Fluid Flow TM

ambient temperature liquid amnion

Instructions for Use

PRODUCT DESCRIPTION

BioLab Fluid Flow is an ambient temperature (25±7°C, 77±13°F) stored liquid allograft derived from the amniotic
TM
fluid within the placenta to advance soft tissue repair, replacement, and reconstruction.
CONTENTS
This package contains a human tissue allograft [Human Cellular and Tissue Based Product (HCT/P)] for transplantation
regulated by the US Food and Drug Administration under 21 CFR Part 1271. In addition to this product insert, the
following items should be included in the product package:

One Outer Box One Allograft One Set of Supplemental One Peel-Pouch
Patient Tracking Tracking Labels per Vial per Vial
Record per Vial (Containing Graft)
PREPARATION & APPLICATION STORAGE & HANDLING

Using aseptic technique, peel open clear
1 product pouch, then place the vial onto a
sterile field.

Product can be stored Dosing is determined by the
If mixing is necessary*, remove the cap at ambient temperature. physician, depending on the
2 and add sterile saline or other fluids, and (25±7°C, 77±13°F) amount or extent of damaged
then replace the cap. or inadequate tissue.

HCT/P RECORD TRACKING
Gently agitate after diluting. If not being
3 mixed, gently roll vial in hands. Mix in
syringe for larger volumes if necessary.
Recipient records must be maintained for the purpose of
tracking tissue post-transplant per The Joint Commission
Open vial, draw contents into syringe and FDA requirements. Supplemental labels, which
4 with 18G or smaller needle. Change to indicate the tissue ID number, are contained in this package
a 21G - 23G needle for injection.
to aid in the tracking process. The allograft ID number
must be recorded in the operative record. The Allograft
Inject at 45 degree angle, injecting Tracing Record must be completed and returned to BioLab
5 clockwise throughout the site to provide
maximum coverage. Sciences.
PROCESSING
Inject fluid slowly to allow the product The HCT/Ps are processed in a controlled environment
6 to settle into the patient’s connective
tissue. cleanroom, using processes designed to prevent
contamination of the tissues. Tissues are exposed to
antibiotics during the initial processing phase and
Apply the product directly into the area
7 of damaged or inadequate connective subsequently rinsed using sterile saline.
tissue.

*Mix at up to a 2:1 ratio, depending on the desired total injectable volume for the intended injection site. Larger volumes may need to be
mixed in syringe. Product may be combined with sterile saline or other fluids.