FDA UDI
In Commercial Distribution
🇺🇸 United States
Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE
DI: 05055788776901
·
Model: 2105488-004
·
FLEXICARE MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE
- Primary DI
- 05055788776901
- Version / Model
- 2105488-004
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-18
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- b981aa0f-ca2c-49a4-8a7a-dfa47e878f50
Device Description
Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 42601 | Straight/elbow breathing circuit connector, reusable | A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055788776901 | GS1 |