Bivona
- Primary DI
- 10887709194196
- Brand
- Bivona
- Company
- ICU MEDICAL, INC.
- Model
- FT26EN70NSC177N
- Device description
- FT26EN70NSC177N Bivona DI: Non-Adjustable-Wired_Non-Sterile
- Published
- 2026-05-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| JOH | Tube tracheostomy and tube cuff |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K923878 | 000 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1992-12-29 | JOH |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10887709194196 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10887709194196 | 10887709194196 |
GMDN Terms
| Term | Definition |
|---|
| Tracheostomy tube, reinforced, non-customized, reusable | An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 118380146
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|
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