FDA UDI
In Commercial Distribution
🇺🇸 United States
Viperslide
DI: 10852528005121
·
Model: VPR-SLD2
·
Cardiovascular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Viperslide
- Primary DI
- 10852528005121
- Version / Model
- VPR-SLD2
- Catalog Number
- 72031-01
- Company Name
- Cardiovascular Systems, Inc.
- Labeler DUNS
- 024954518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-15
- Public Version
- 4
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- 38b3a3f1-a891-44a1-b1d0-48ac2d4255fb
Device Description
VIPERSLIDE, 100ML BAG, 10 PK
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61201 | Atherectomy system lubricant | A sterile substance intended to reduce friction between components of a mechanical atherectomy system (e.g., guidewire and rotating drive shaft) during operation. It is typically a lipid-based emulsion that is pumped through a catheter during the procedure, by a dedicated pump, to provide lubrication and sometimes cooling with added saline. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10852528005121 | GS1 |
Customer Contacts
- Phone
- +1(877)274-0360
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze Viperslide. If accidently frozen, discard the bag.