AccessGUDID - DEVICE: PiCCO Catheter (04250094500948)

GUDID

Device Identifier (DI) Information

Brand Name: PiCCO Catheter
Version or Model: PV2013L07-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pulsion Medical Systems SE

Primary DI Number: 04250094500948
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316093673 *Terms of Use

Device Description: 3F Thermodilution catheter, 70mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
K171620	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: 70 Millimeter

Device Record Status

Public Device Record Key: 3d76daf0-65c1-4233-9cd5-2c6201ddeec4
Public Version Date: October 13, 2021
Public Version Number: 3
DI Record Publish Date: April 11, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24250094500942	10	14250094500945		In Commercial Distribution	Box
14250094500945	5	04250094500948		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49894599140
Email: zentrale.pulsion@getinge.com

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