AccessGUDID - DEVICE: Tubing Pack (00607567203952)

GUDID

Device Identifier (DI) Information

Brand Name: Tubing Pack
Version or Model: BO-T 6600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701052324
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567203952
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: BO-RF32 Rotaflow

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
31718	Cardiopulmonary bypass system centrifugal pump	A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWE	Tubing, Pump, 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: 853262c5-f887-4c71-92be-101391db132c
Public Version Date: May 19, 2020
Public Version Number: 6
DI Record Publish Date: October 30, 2015