FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset Homefill Tubing Connector - Coiled
DI: 00848530084455
·
Model: RES039
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sunset Homefill Tubing Connector - Coiled
- Primary DI
- 00848530084455
- Version / Model
- RES039
- Catalog Number
- RES039
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-25
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 6011e05b-e9a7-4d63-95cc-560ba99b971a
Device Description
Sunset Homefill Tubing Connector - Coiled
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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14239 | High-pressure medical gas hose | A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20848530084459 | GS1 | 5 | In Commercial Distribution | ||
| Package | 10848530084452 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00848530084455 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]