CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
Device Facts
| Record ID | K960921 |
|---|---|
| Device Name | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE |
| Applicant | Codan Medlon, Inc. |
| Product Code | LHI · General Hospital |
| Decision Date | Apr 17, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Intended Use
The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set.
Device Story
Sterile, nonpyrogenic, multiple-dose vial adapter; facilitates medication transfer between vials, syringes, and IV sets. Incorporates 0.20 µm pressure-resistant hydrophobic filter. Used in clinical settings for drug preparation and administration. Benefits include closed-system-like transfer and filtration of solutions.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Sterile, nonpyrogenic, disposable vial adapter. Features 0.20 µm hydrophobic filter. Materials identical to predicate devices.
Indications for Use
Indicated for the preparation and withdrawal of medications and cytotoxic solutions from multiple dose vials.
Regulatory Classification
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Predicate Devices
- Acacia Transfer Pins and Micron Filter (K901063)
- B. Braun Mini-Spike® Dispensing Pin™ (K925401)
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- K955595 — SAFELINE MULTIDOSE VIAL ADAPTER · Mcgaw, Inc. · Mar 6, 1996
- K190816 — Vial Adapter Ø20 mm , Vial Adapter Ø13 mm · Avenir Performance Europeenne Medical (Apem) · Nov 19, 2019
