AccessGUDID - DEVICE: CS100 Accessory Kit, English International (AAMI), 110 V (10607567111926)

GUDID

Device Identifier (DI) Information

Brand Name: CS100 Accessory Kit, English International (AAMI), 110 V
Version or Model: 0020-00-0463-33
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0020-00-0463-33
Company Name: Datascope Corp.

Primary DI Number: 10607567111926
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 040874329 *Terms of Use

Device Description: CS100 Accessory Kit, English International (AAMI), 110 V

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:	Yes
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?
36340	Intra-aortic balloon pump	An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSP	System, Balloon, Intra-Aortic And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031636	000

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: b1567972-0987-4a1b-a1a1-617267e2da76
Public Version Date: February 27, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2016