ODIClass II
Administration Set Docking Station
21 CFR 880.5440 / General Hospital
ODI is the FDA product code for Administration Set Docking Station, a class II device type, regulated under 21 CFR 880.5440. FDA's definition for this code reads: "Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- ODI
- Device name
- Administration Set Docking Station
- FDA definition
- Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
- Regulation
- 21 CFR 880.5440
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code ODI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
Applicants with the most clearances
Product code ODI| Applicant | Clearances |
|---|---|
| Baxa Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code ODI.
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