FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 06974599110478
·
Model: TRI-2
·
Changsha Magill Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- NA
- Primary DI
- 06974599110478
- Version / Model
- TRI-2
- Company Name
- Changsha Magill Medical Technology Co., Ltd.
- Labeler DUNS
- 703075567
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-01-13
- Public Version
- 2
- Public Version Date
- 2025-02-20
- Public Version Status
- Update
- Public Device Record Key
- 818563fc-1e37-4d8c-aebc-4050314cd2bb
- Distribution End Date
- 2025-01-22
Device Description
A 3-way connector where one of the open is capped. Allow passage of suction cathers or bronchoscopes.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63465 | Closed-suction breathing circuit connector/switch | A sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86974599110474 | GS1 | ||||
| Primary | 06974599110478 | GS1 |