FDA UDI
In Commercial Distribution
🇺🇸 United States
Streamway
DI: 10862675000306
·
Model: 4501.3000
·
SKYLINE MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Streamway
- Primary DI
- 10862675000306
- Version / Model
- 4501.3000
- Catalog Number
- STM 2000
- Company Name
- SKYLINE MEDICAL INC.
- Labeler DUNS
- 024774680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 15d9da6c-6ffa-4028-86cf-2b5774b4101e
Device Description
Direct to drain liquid fluid waste management system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36778 | General-purpose suction system, vacuum | An assembly of devices designed to evacuate fluid, tissue, gas, or foreign materials from a body cavity or lumen by means of suction. It is connected via dedicated vacuum tubing to the vacuum terminal unit (wall outlet) of a vacuum pipeline system and powered via a hospital's central vacuum system. It generally includes a regulator, tubing, an overflow trap, plastic/glass collection container(s), a suction tip, and possibly moisture/microbial filters. The regulator controls the vacuum in the suction tubing for the removal of materials into the collection container. This system can be used in a wide variety of hospital settings, but is limited to connection to a central vacuum system. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10862675000306 | GS1 |
Customer Contacts
- Phone
- 651-389-4800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 30 | Inch |