FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset Flex HME
DI: 00848530089054
·
Model: RES027FLEX
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sunset Flex HME
- Primary DI
- 00848530089054
- Version / Model
- RES027FLEX
- Catalog Number
- RES027FLEX
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 1
- Public Version Date
- 2018-10-18
- Public Version Status
- New
- Public Device Record Key
- 6f33176b-1c1a-45fa-9f07-4b46e14ba634
Device Description
Sunset Flex HME
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 |
|---|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Anesthesiology | 868.5375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35530 | Heat/moisture exchanger, single-use | A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530089054 | GS1 | ||||
| Package | 10848530089051 | GS1 | 40 | In Commercial Distribution | ||
| Package | 20848530089058 | GS1 | 8 | In Commercial Distribution |