FDA UDI
In Commercial Distribution
🇺🇸 United States
Tracheostomy and Suction Accessory
DI: 00848530106300
·
Model: TRAA003P
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tracheostomy and Suction Accessory
- Primary DI
- 00848530106300
- Version / Model
- TRAA003P
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-02
- Public Version
- 1
- Public Version Date
- 2025-07-10
- Public Version Status
- New
- Public Device Record Key
- bd731089-f7e0-4854-b2b1-bac2a37c0c0b
Device Description
Flexible Trach Adapter, 15mm Cuff Comparable to OEM# 1073863
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62966 | Artificial airway cuff inflation tubing | A length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530106300 | GS1 | ||||
| Package | 10848530106307 | GS1 | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 8775786738
- [email protected]