AccessGUDID - DEVICE: HF Std Pack with BC 140 Plus (00607567206472)

GUDID

Device Identifier (DI) Information

Brand Name: HF Std Pack with BC 140 Plus
Version or Model: T 8037
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701066992
Company Name: DATASCOPE CORP.

Primary DI Number: 00607567206472
Issuing Agency: GS1
Commercial Distribution End Date: June 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: BC 140 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):	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?
44601	Haemofilter	A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. 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: 6808b4d3-2acb-4791-8bfe-10b5e9125b51
Public Version Date: June 11, 2019
Public Version Number: 4
DI Record Publish Date: March 22, 2017