FDA UDI
In Commercial Distribution
🇺🇸 United States
Firesafe Valve and Nozzle Kit
DI: 00848530083458
·
Model: RES010FND-KIT
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Firesafe Valve and Nozzle Kit
- Primary DI
- 00848530083458
- Version / Model
- RES010FND-KIT
- Catalog Number
- RES010FND-KIT
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 2
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 00c0d650-5a64-4351-8f8b-4e5a50a4a126
Device Description
This kit contains: 1 RES010 Firesafe Bidirectional Cannula Valve, 1 RES010FND-1 Firesafe Nozzel.
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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60391 | Oxygen tubing fire safety valve | A safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530083458 | GS1 | ||||
| Unit of Use | 10848530083455 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]