FDA.reportPublic FDA data

Viperslide

Primary DI
30852528005125
Brand
Viperslide
Company
Cardiovascular Systems, Inc.
Model
VPR-SLD2
Catalog number
72031-01
Device description
VIPERSLIDE, 100ML BAG, 10 PK
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCXCatheter, Coronary, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCXCatheter, Coronary, AtherectomyUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30852528005125PackageGS110In Commercial Distribution
10852528005121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085252800512530852528005125
1085252800512110852528005121

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy system lubricantA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze Viperslide. If accidently frozen, discard the bag.
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-259-1600customerservice@csi360.com

Regulatory Flags#

DUNS number
024954518
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852528005817Diamondback PeripheralDBP-EX-125MIC1457-10030-012019-02-04
10852528005824Diamondback PeripheralDBP-EX-125SOL1457-10030-022019-02-04
10852528005831Diamondback PeripheralDBP-EX-150SOL1457-10030-032019-02-04
10852528005848Diamondback PeripheralDBP-EX-200SOL1457-10030-042019-02-04
10852528005862Diamondback PeripheralDBP-EX-125SOL757-10030-062019-02-04
10852528005879Diamondback PeripheralDBP-EX-125SOL2007-10030-072019-02-04
10852528005886Diamondback PeripheralDBP-EX-150SOL2007-10030-082019-02-04
10852528005893Diamondback PeripheralDBP-EX-175SOL1807-10030-092019-02-04
10852528005909Diamondback PeripheralDBP-EX-150CLA1457-10030-102019-02-04
10852528005916Diamondback PeripheralDBP-EX-200CLA1457-10030-112019-02-04
10852528005855Diamondback PeripheralDBP-EX-125MIC757-10030-052019-02-04
10850000491172Diamondback PeripheralDBP-125MICRO1457-10057-012019-11-13
10850000491189Diamondback PeripheralDBP-125SOLID1457-10057-022019-11-13
10850000491196Diamondback PeripheralDBP-150SOLID1457-10057-032019-11-13
10850000491202Diamondback PeripheralDBP-200SOLID1457-10057-042019-11-13
10850000491219Diamondback PeripheralDBP-125SOLID2007-10057-052019-11-13
10850000491226Diamondback PeripheralDBP-150SOLID2007-10057-062019-11-13
10850000491233Diamondback PeripheralDBP-175SOLID1807-10057-072019-11-13
10850000491240Diamondback PeripheralDBP-150CLASS1457-10057-082019-11-13
10850000491257Diamondback PeripheralDBP-200CLASS1457-10057-092019-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506005559Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
00191506005566Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
10850026568698Diamondback CoronaryCardiovascular Systems, Inc.MCX2023-06-16
10850026568087Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
10850026568100Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
08714729996231RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996255RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996248RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996262RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729999560ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999577ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999584ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999591ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999607ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999614ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999621ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999638ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
10850000491356Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10850000491363Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10852528005701ViperWireCardiovascular Systems, Inc.MCX2019-09-23
30852528005705Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-09-23
10852528005787Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-02-04
10852528005800Diamondback CoronaryCardiovascular Systems, Inc.MCX2018-07-20
08714729893356ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893363ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893370ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893387ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893394ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893400ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893417ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11