FDA UDI
In Commercial Distribution
🇺🇸 United States
Humidifier Connector with Tube
DI: 00848530089825
·
Model: HUM008
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Humidifier Connector with Tube
- Primary DI
- 00848530089825
- Version / Model
- HUM008
- Catalog Number
- HUM008
- 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
- fcdef645-4af7-408f-82b0-9ae534771887
Device Description
Humidifier Connector with Tube (1/pack). Compatible with most continuous flow oxygen concentrator with barbed outlets including Respironics and Invacare.
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 |
|---|---|---|---|---|
| 44705 | Inhalation-therapy adaptor, reusable | A small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system) when the connection is not compatible (e.g., when the humidifier and the sterile water pack are of different manufacture). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530089825 | GS1 | ||||
| Package | 10848530089822 | GS1 | 10 | In Commercial Distribution | ||
| Package | 20848530089829 | GS1 | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]