FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray
DI: 00848530070076
·
Model: TUB006
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray
- Primary DI
- 00848530070076
- Version / Model
- TUB006
- Catalog Number
- TUB006
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- 0b2a859c-a98e-4160-81b6-1bf62b6e5991
Device Description
Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray
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 |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | 868.5975 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61833 | Inspiratory/expiratory limb respiratory tubing, reusable | A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848530070073 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00848530070076 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]