FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 06974599110508
·
Model: EXT-1
·
Changsha Magill Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- NA
- Primary DI
- 06974599110508
- Version / Model
- EXT-1
- Company Name
- Changsha Magill Medical Technology Co., Ltd.
- Labeler DUNS
- 703075567
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- 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
- a9ecfb7b-7b42-4300-94cc-0b975fa98b02
- Distribution End Date
- 2025-01-22
Device Description
This extension tube can be connected to breathing circuit independently or together with elbow connector when necessary.
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 |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. 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 | 86974599110504 | GS1 | ||||
| Primary | 06974599110508 | GS1 |