Metrix-Secure 58794 - Secure 1 Leg Gravity Fill Set, Vented Spike, DEHP & Latex-Free, 50/CS
1 Leg Gravity Fill Set
Features
- Detachable Gravity Fill Legs with female screw connector.
- For Secure Legless bags with male screw connector.
- This product is not made with natural rubber latex or DEHP.
- Available in 1, 2 or 3 leg versions.
- Fill legs have vented spike.
Device Characteristics
- What MRI safety information does the labeling contain? Labeling does not contain MRI Safety Information
- Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No
- Device labeled as "Not made with natural rubber latex": Yes
- For Single-Use: Yes
- Prescription Use (Rx): Yes
- Over the Counter (OTC): No
- Kit: No
- Combination Product: No
- Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): No
GMDN Definition
A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
What is Luer Adapter?
Luer Adapters are specifically designed to work in a variety of applications by securely connecting a male or female luer to each other.
Sterilization
- Device Packaged as Sterile: Yes.
- Requires Sterilization Prior to Use: No.
Package DI (Device Identifier)
- Package DI Number: 50812496011911
- Quantity per Package: 50
- Contains DI Package: 00812496011916
- Package Discontinue Date:
- Package Type: Cardboard Carton.
DEHP Free
Infusion Therapy Standards of Practice advise to usee administration sets free of di-ethylhexyl-phthalate (DEHP) to administer lipid-based infusates, such as IVFE or TNA. DEHP is lipophilic and is extracted into the lipid solution with commonly used polyvinyl chloride administration sets and containers. DEHP is considered a toxin, and studies have demonstrated increased DEHP levels in lipid solutions, which is especially a risk with neonatal, pediatric, and long-term home care patients (42).
