FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset HomeFill Rack for Platinum - White
DI: 00848530090005
·
Model: RES039-RACKW
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sunset HomeFill Rack for Platinum - White
- Primary DI
- 00848530090005
- Version / Model
- RES039-RACKW
- Catalog Number
- RES039-RACKW
- 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
- 1
- Public Version Date
- 2018-10-26
- Public Version Status
- New
- Public Device Record Key
- 8ba0e6d4-531b-4940-a212-893b9d1c85ac
Device Description
Sunset HomeFill Rack for Platinum - White
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41756 | Gas cylinder holder | A device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848530090002 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00848530090005 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]