AccessGUDID - DEVICE: Terumo® Advanced Perfusion System 1 (00886799000595)

GUDID

Device Identifier (DI) Information

Brand Name: Terumo® Advanced Perfusion System 1
Version or Model: 801238
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 801238
Company Name: Terumo Cardiovascular Systems Corporation

Primary DI Number: 00886799000595
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177655466 *Terms of Use

Device Description: The 33" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles

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":	No
For Single-Use:	No
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?
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151349	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e308dd6-c449-460b-9f07-69926b4a75b6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016