FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 06974599110485
·
Model: EJT-1
·
Changsha Magill Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NA
- Primary DI
- 06974599110485
- Version / Model
- EJT-1
- Company Name
- Changsha Magill Medical Technology Co., Ltd.
- Labeler DUNS
- 703075567
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- 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
- bb99417e-9c86-4b75-89b9-e68e55171710
- Distribution End Date
- 2025-01-12
Device Description
This device helps to hold the endotracheal tube in position when exchanging a in situ laryngeal mask after endotracheal tube is in place.
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 |
|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | Anesthesiology | 868.5790 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60376 | Endotracheal tube stabilization rod | A non-sterile device intended to be used to facilitate exchange of an in situ laryngeal airway for an endotracheal tube (ETT) by stabilizing the position of the inserted ETT as the laryngeal airway is withdrawn. It typically consists of a semi-flexible rod which functions as an extension of the ETT during the exchange. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86974599110481 | GS1 | ||||
| Primary | 06974599110485 | GS1 |