FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxygen Delivery Adapter for T-HME
DI: 00848530062354
·
Model: RES027A
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxygen Delivery Adapter for T-HME
- Primary DI
- 00848530062354
- Version / Model
- RES027A
- Catalog Number
- RES027A
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 1
- Public Version Date
- 2018-08-31
- Public Version Status
- New
- Public Device Record Key
- d857f0cf-63fe-414a-9062-49858f09bc1e
Device Description
Oxygen Delivery Adapter for T-HME (1/pack)
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
- 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 |
|---|---|---|---|---|
| 42988 | Low-pressure tubing connector, reusable | A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530062354 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 800cc |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile