FDA UDI
In Commercial Distribution
🇺🇸 United States
Scope Assist Flushing Sink (SAFS)
DI: FLUSHINGSINKMODELS8
·
Model: S8
·
Wassenburg Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scope Assist Flushing Sink (SAFS)
- Primary DI
- FLUSHINGSINKMODELS8
- Version / Model
- S8
- Company Name
- Wassenburg Medical, Inc.
- Labeler DUNS
- 118762097
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-16
- Public Version
- 5
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 948a824c-24d0-4d49-9009-b82dd00727a6
Device Description
Device to flush endoscopes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35012 | Endoscope washer/disinfector | A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | FLUSHINGSINKMODELS8 | HIBCC |
Customer Contacts
- Phone
- 215-364-1477
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162120 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not fork lift
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile