FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset Healthcare Solutions Silicone Suction Tubing Connector - 3.5in
DI: 00848530060428
·
Model: RES024
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Sunset Healthcare Solutions Silicone Suction Tubing Connector - 3.5in
- Primary DI
- 00848530060428
- Version / Model
- RES024
- Catalog Number
- RES024
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 84bebb2e-c735-472d-a087-15a119200b85
Device Description
Silicone Suction Tubing Connector 10 grams 3.5in in length 2.65mm wall thickness; OD 13.3mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAZ | Tubing, Noninvasive | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16779 | Suction/irrigation tubing, single-use | A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20848530060422 | GS1 | Corrugated Box | 10 | In Commercial Distribution | |
| Package | 10848530060425 | GS1 | Plastic Bag | 10 | In Commercial Distribution | |
| Primary | 00848530060428 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 8 | Millimeter | |
| Outer Diameter | 13.3 | Millimeter | |
| Length | 3.5 | Inch |