AccessGUDID - DEVICE: HF Std Pack with BC 60 Plus (00607567206489)

GUDID

Device Identifier (DI) Information

Brand Name: HF Std Pack with BC 60 Plus
Version or Model: T8036
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701066990
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567206489
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: BC 60 Plus

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:	No
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?
35441	Cardiopulmonary bypass system blood 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.	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: adbcbb02-3fc6-497d-b783-93cdc5bb955b
Public Version Date: December 08, 2022
Public Version Number: 6
DI Record Publish Date: January 15, 2016