AccessGUDID - DEVICE: Adult Custom Pack (00607567202993)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Custom Pack
Version or Model: BEQ-TOP- 32100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701054438
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567202993
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: 701053325 BEQ-HMOD 70000-USA Adult Quadrox iD 701020489 BEQ-RF32 RotaFlow 701045763 Gas Filter

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?
36347	Cardiopulmonary bypass system roller pump	A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.	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: 605e27fd-1798-44d3-9dd5-6fd9f64de23c
Public Version Date: December 05, 2018
Public Version Number: 3
DI Record Publish Date: October 26, 2015