FDA UDI
In Commercial Distribution
🇺🇸 United States
SWIK
DI: 00860349001713
·
Model: SWK-200
·
Saliva Management Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
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
- SWIK
- Primary DI
- 00860349001713
- Version / Model
- SWK-200
- Company Name
- Saliva Management Systems, Inc.
- Labeler DUNS
- 119148960
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-05
- Public Version
- 1
- Public Version Date
- 2024-05-13
- Public Version Status
- New
- Public Device Record Key
- 6bc5ea46-e959-4a2b-b628-31c01affd580
Device Description
Non-Invasive oral secretion management tool.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860349001713 | GS1 | ||||
| Package | 10860349001703 | GS1 | 2mil Poly Bag | 10 | Not in Commercial Distribution | 2024-05-05 |
| Package | 30860349001714 | GS1 | 2mil Poly Bag | 25 | Not in Commercial Distribution | 2024-05-05 |
| Package | 20860349001717 | GS1 | 2mil Poly Bag | 50 | Not in Commercial Distribution | 2024-05-05 |
| Package | 10860349001710 | GS1 | 2mil Poly Bag | 100 | Not in Commercial Distribution | 2024-05-05 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit