AccessGUDID - DEVICE: Diamondback Coronary (10852528005800)

GUDID

Device Identifier (DI) Information

Brand Name: Diamondback Coronary
Version or Model: SIP-3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-10037-07
Company Name: Cardiovascular Systems, Inc.

Primary DI Number: 10852528005800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024954518 *Terms of Use

Device Description: SALINE INFUSION PUMP (SIP)

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:	No
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?
57787	Atherectomy system saline/lubricant pump	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to inject cooled normal sterile saline and/or surgical lubricant via the system’s dedicated catheter into the site of crossing a chronic partial occlusion (CPO) or chronic total occlusion (CTO) in both coronary and peripheral arteries. The device functions as a pump and will typically work in synchronization with the generator, whereby it may also function as the mains adaptor/control unit. This is a reusable 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05b62739-85ee-4774-bb13-3366ec1b94f6
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: July 20, 2018