Baxter 2B8124 - SET, ALL-IN-ONE EMPTY CONT. (2000ML) W/3, EACH
Empty ALL-IN-ONE E.V.A Container for Gravity Transfer
ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 2000 mL Capacity
The All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
Intended Use
The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
Technological Characteristics and Substantial Equivalence:
The All-In-One Container is substantially equivalent to Baxter's current legally marketed All-In-One Container cleared November 3, 1998 (K983294).
Discussion of Nonclinical Tests:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.
The All-In-One Container is substantially equivalent to the predicate devices.
Ethylene-vinyl acetate (EVA)
Ethylene-vinyl acetate (EVA), also known as poly (ethylene-vinyl acetate) (PEVA), is the copolymer of ethylene and vinyl acetate. The weight percent vinyl acetate usually varies from 10 to 40%, with the remainder being ethylene.
 |
| a close-up picture of open celled EVA |
EVA is used in biomedical engineering applications as a drug delivery device. The polymer is dissolved in an organic solvent (e.g., dichloromethane). Powdered drug and filler (typically an inert sugar) are added to the liquid solution and rapidly mixed to obtain a homogeneous mixture. The drug-filler-polymer mixture is then cast into a mold at -80 ? and freeze dried until solid. These devices are used in drug delivery research to slowly release a compound. The polymer does not biodegrade within the body, but is quite inert and causes little or no reaction following implantation.
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 |
Sterilization
| Device Packaged as Sterile: | Yes |
| Requires Sterilization Prior to Use: | No |
Product Specifications
| Manufacturer No. | 2B8124 |
| Brand | All-In-One |
| Manufacturer | Baxter |
| Latex | Not Made with Natural Rubber Latex |
| Rx Only | Yes |
| Application | Medication Delivery Bag (empty) |
| Capacity | 2000 mL |
Packing Information
| Length: | 16 IN |
| Width: | 14.5 IN |
| Height: | 8 IN |
| Volume: | 1.07 FC |
| Weight: | 6 LB |
| Pack Factor: | 15 |
