FDA UDI
In Commercial Distribution
🇺🇸 United States
Celon Wet Bands 66 x 120mm
DI: 00848530101824
·
Model: WB66120
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1500
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Basic Information
- Brand Name
- Celon Wet Bands 66 x 120mm
- Primary DI
- 00848530101824
- Version / Model
- WB66120
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1500
- Record Status
- Published
- Publish Date
- 2024-03-20
- Public Version
- 1
- Public Version Date
- 2024-03-28
- Public Version Status
- New
- Public Device Record Key
- ac352366-a11c-4c27-9c60-271c6b1c4a91
Device Description
Celon Wets Bands 66x120mm
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
- Yes
- 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 |
|---|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | Anesthesiology | 868.2340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61365 | Medical gas flowmeter, Thorpe tube | A device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10848530101821 | GS1 | ||||
| Primary | 00848530101824 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]