FDA UDI
In Commercial Distribution
🇺🇸 United States
Via‐Guard®
DI: 00862630000313
·
Model: SMK 200
·
SURGIMARK INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Via‐Guard®
- Primary DI
- 00862630000313
- Version / Model
- SMK 200
- Catalog Number
- SMK 200
- Company Name
- SURGIMARK INC
- Labeler DUNS
- 556486553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-01
- Public Version
- 3
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 10259c46-0377-42bf-94cd-ebb915b04cf2
Device Description
Via-Guard® Vascular Suction Set
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 |
|---|---|---|---|---|
| JOL | Catheter And Tip, Suction | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35917 | Surgical/emergency suction cannula, non-illuminating, single-use | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862630000313 | GS1 | ||||
| Package | 10862630000310 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Package | 20862630000317 | GS1 | Case | 10 | In Commercial Distribution |