FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
DI: 04544050055789
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Model: I.D. 5.5MM (FR.24), 400MM LONG TYPE
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FUJI SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
- Primary DI
- 04544050055789
- Version / Model
- I.D. 5.5MM (FR.24), 400MM LONG TYPE
- Catalog Number
- 1200824
- Company Name
- FUJI SYSTEMS CORPORATION
- Labeler DUNS
- 715919973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5cacadbd-c949-421a-854d-d98ca985c681
Device Description
Endotracheal Tubes are intended for oral intubation and are indicated for use in airway management and other suitable medical application.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46569 | Reinforced endotracheal tube, single-use | An armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04544050055789 | GS1 |