FDA UDI
In Commercial Distribution
🇺🇸 United States
Deluxe Tubing Wrap
DI: 00848530020057
·
Model: CAP2002
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Deluxe Tubing Wrap
- Primary DI
- 00848530020057
- Version / Model
- CAP2002
- Catalog Number
- CAP2002
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-29
- Public Version
- 1
- Public Version Date
- 2018-08-29
- Public Version Status
- New
- Public Device Record Key
- 8d73eb09-7033-4daa-9f7f-fde665491e9f
Device Description
6ft Nylon CPAP Tubing Wrap
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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32202 | Aerosol delivery tubing | A non-sterile length of a flexible, hollow tube, typically large bore (e.g., 22 mm), used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer for the delivery of aerosolized humidification, typically oxygen enriched. It is typically supplied in standard coil lengths and is cut by clinical staff to usable lengths. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530020057 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]