AccessGUDID - DEVICE: PiCCO Catheter (04250094500634)

GUDID

Device Identifier (DI) Information

Brand Name: PiCCO Catheter
Version or Model: PV2013L07N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Pulsion Medical Systems SE

Primary DI Number: 04250094500634
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 316093673 *Terms of Use

Device Description: 3F Thermodilution catheter, 7cm

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:	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?
64576	Thermal dilution peripheral artery catheter	A short, thin, flexible tube intended for short-term (<= 30 days) percutaneous placement into a peripheral artery (excluding pulmonary artery) during measurement/monitoring of haematological parameters (e.g., arterial pressure, cardiac output/index) using thermal dilution techniques. It is designed to be used as the downstream sensor during thermal dilution, whereby it is intended to be used in conjunction with a central venous catheter (intended for upstream solution introduction) and an external monitor. It includes an electronic thermistor and may include devices dedicated to introduction/function. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRB	Probe, Thermodilution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072364	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
Catheter Gauge: 3 French
Length: 7 Centimeter

Device Record Status

Public Device Record Key: 77978c7e-0155-415f-a6a4-9c51d087c87e
Public Version Date: October 13, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016