FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SYSTEM 83 PLUS
DI: SYSTEM83PLUS9
·
Model: SYSTEM 83 PLUS 9
·
Wassenburg Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SYSTEM 83 PLUS
- Primary DI
- SYSTEM83PLUS9
- Version / Model
- SYSTEM 83 PLUS 9
- Company Name
- Wassenburg Medical, Inc.
- Labeler DUNS
- 118762097
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 6
- Public Version Date
- 2025-03-19
- Public Version Status
- Update
- Public Device Record Key
- 1fa36d32-dec9-4598-a194-01f170a4241d
- Distribution End Date
- 2023-07-27
Device Description
A device to disinfect 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
- 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 |
|---|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66649 | Endoscope washer-disinfector (chemical) | An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | SYSTEM83PLUS9 | HIBCC | ||||
| Package | B21583PLUS9 | HIBCC | Corrugate Box | 1 | Not in Commercial Distribution |
Customer Contacts
- Phone
- 215-364-1477
- [email protected]
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