AccessGUDID - DEVICE: PulsioFlex (04250094501525)

GUDID

Device Identifier (DI) Information

Brand Name: PulsioFlex
Version or Model: PC4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pulsion Medical Systems SE

Primary DI Number: 04250094501525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316093673 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	No
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?
42873	Invasive arterial pressure cardiac output/oximetry monitor	A mains electricity (AC-powered) device, which may have internal rechargeable batteries, designed to continuously measure and display arterial pressure cardiac output (APCO) [minimally-invasive cardiac output estimation from arterial blood pressure waveforms] and haemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter. It is typically used in the operating room or intensive care unit (ICU) and may also calculate other haemodynamic parameters including cardiac index, stroke volume, and/or systemic vascular resistance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122121	000
K172259	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: 1cb101da-739e-401f-8e4d-fd8df71b9e72
Public Version Date: October 13, 2021
Public Version Number: 5
DI Record Publish Date: March 10, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES