AccessGUDID - DEVICE: Viperslide (10852528005121)

GUDID

Device Identifier (DI) Information

Brand Name: Viperslide
Version or Model: VPR-SLD2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72031-01
Company Name: Cardiovascular Systems, Inc.

Primary DI Number: 10852528005121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024954518 *Terms of Use

Device Description: VIPERSLIDE, 100ML BAG, 10 PK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCX	Catheter, Coronary, Atherectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not freeze Viperslide. If accidently frozen, discard the bag.
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38b3a3f1-a891-44a1-b1d0-48ac2d4255fb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30852528005125	10	10852528005121		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 651-259-1600
Email: customerservice@csi360.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES