AccessGUDID - DEVICE: Descending Thoracic Pack (00060756720230)

GUDID

Device Identifier (DI) Information

Brand Name: Descending Thoracic Pack
Version or Model: BEQ-T 22800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701049506
Company Name: DATASCOPE CORP.

Primary DI Number: 00060756720230
Issuing Agency: GS1
Commercial Distribution End Date: May 05, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: BEQ-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):	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiopulmonary bypass system tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiopulmonary bypass system tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DWE	Tubing, Pump, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080592	000

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: 7dc95531-fb40-47bf-aa1e-2bb5ece734e4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 22, 2016