FDA UDI
In Commercial Distribution
🇺🇸 United States
Tracheostomy and Suction Accessory
DI: 00848530106256
·
Model: VEN77230512M
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Tracheostomy and Suction Accessory
- Primary DI
- 00848530106256
- Version / Model
- VEN77230512M
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-03
- Public Version
- 1
- Public Version Date
- 2025-06-11
- Public Version Status
- New
- Public Device Record Key
- 9184135a-5605-4701-824f-17995816398d
Device Description
Adult 72hr Closed Suction Catheter Tracheostomy - 12Fr 305mm
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
- Yes
- 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 |
|---|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 878.4680 | 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 |
|---|---|---|---|---|---|---|
| Package | 10848530106253 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00848530106256 | GS1 | ||||
| Package | 20848530106250 | GS1 | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 8775786738
- [email protected]