AccessGUDID - DEVICE: Cardioplegia Accessory Pack (00607567205802)

GUDID

Device Identifier (DI) Information

Brand Name: Cardioplegia Accessory Pack
Version or Model: BO-T 30301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701066188
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567205802
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
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?
16163	Cardioplegia solution administration kit	A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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 [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f035c20-da7b-4c9e-982e-aa86dd0761a0
Public Version Date: October 19, 2021
Public Version Number: 6
DI Record Publish Date: July 11, 2016