FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxygen Kit: (2) RES003, (1) RES018, (6) RES1107, (1) RES3025G, (1) RES3040G
DI: 00848530090302
·
Model: RESKIT001B
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxygen Kit: (2) RES003, (1) RES018, (6) RES1107, (1) RES3025G, (1) RES3040G
- Primary DI
- 00848530090302
- Version / Model
- RESKIT001B
- Catalog Number
- RESKIT001B
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-11
- Public Version
- 2
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- a7326af4-52c1-40a0-be6c-c7e9249def74
Device Description
Oxygen Kit: (2) RES003, (1) RES018, (6) RES1107, (1) RES3025G, (1) RES3040G
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60856 | Oxygen administration kit | A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530090302 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]