Baxter 2J8002 - Cont.Fluid Non-DEHP Empty 250ml 48/CS
Empty INTRAVIA Container with Non-DEHP Fluid Path, 250 mL
INTRAVIA Container, 250 mL Capacity
Empty INTRAVIA Container with Non-DEHP Fluid Path, 250 mL
INTRAVIA Plastic Container systems
- INTRAVIA Container, 250 mL Capacity
- The solution contact materials in empty 2J INTRAVIA Container
- Radiation - Gamma sterilized
Cautions
- Squeeze and inspect filled bag
- Discard if leaks are found
- Must not be used in series connections
Contains DEHP
Diethyl hexyl Phthalate, A chemical commonly used in PVC tubing; used to yield clarity and soft pliable tubing.
Contains PVC
Polyvinyl chloride (PVC) plastic is used to manufacture a huge number of articles for daily life, e.g. toys, building material such as flooring, cables, as well as medical products. PVC is the most widely used thermoplastic material in medical devices due to its:
Safety
Before medical devices can be used all the components must be fully understood from a toxicological point of view. Consequently all the materials used to make such components have to be thoroughly tested and assessed in the EU before being accepted. Experience based on all available knowledge from international environmental and healthcare authorities shows that PVC is safe. It is the best material existing today which optimises all performance and safety requirements at lowest cost.
Chemical stability
Material used in medical applications must be capable of accepting or conveying a variety of liquids without themselves undergoing any significant changes in composition or properties.
Biocompatibility
Whenever plastics are used in direct contact with the patients tissue or blood, a high degree of compatibility is essential between the tissue/bloodand the material. The significance of this property increases with time over which plastic is in contact with the tissue or blood.PVC is characterised by high biocompatibility, and this can be increased further by appropriate surface modification.
Clarity and transparency
Because of its physical properties, products made from PVC can be formulated with excellent transparency to allow for continual monitoring of fluid flow. If colour-coded application is needed, virtually any colour can be created.
Flexibility, durability and dependability
Not only does PVC offer the flexibility necessary for applications such as blood bags and IV containers, but can also be relied upon for its strength and durability, even under changing temperatures and conditions.
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. | 2J8002 |
| Brand | Intravia |
| Manufacturer | Baxter |
| Latex | Not Made with Natural Rubber Latex |
| Concentration | Rx Only. |
| Application | Medication Delivery Bag (empty) |
| Capacity | 250 mL |
| Port Type | 2 - PVC Ports |
| PVC | Contains PVC |
| DEHP | Non-DEHP |
Packing Information
| Length: | 12 IN |
| Width: | 8.75 IN |
| Height: | 6 IN |
| Volume: | 0.36 FC |
| Weight: | 2 LB |
| Pack Factor: | 48 |
