AccessGUDID - DEVICE: Injectate temperature sensor housing (04250094500153)

GUDID

Device Identifier (DI) Information

Brand Name: Injectate temperature sensor housing
Version or Model: PV4046
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pulsion Medical Systems SE

Primary DI Number: 04250094500153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316093673 *Terms of Use

Device Description: Injectate temperature sensor housing PV4046

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):	No
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?
10615	Thermal-dilution cardiac output unit	A unit that measures the blood flow from the heart using the indicator dilution technique, in which a thermal indicator (e.g., cold saline solution or other indicator solution) is injected upstream of the heart and monitored on the downstream side by a balloon-tipped (flow-directed) catheter with a temperature probe. The measured results are reproduced by this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRB	Probe, Thermodilution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020587	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: cbd27168-8107-4cd1-a840-90bc0220ac6a
Public Version Date: October 13, 2021
Public Version Number: 4
DI Record Publish Date: September 29, 2016