AccessGUDID - DEVICE: EASY logO (04057834029215)

GUDID

Device Identifier (DI) Information

Brand Name: EASY logO
Version or Model: 095264-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RAUMEDIC AG

Primary DI Number: 04057834029215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332785323 *Terms of Use

Device Description: No description.

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?
61452	Invasive-detection multi-parameter physiological monitor, reusable	An electrically-powered device intended for the continuous or intermittent measurement, display, and/or recording of several invasively-detected physiological parameters [e.g., blood pressure, intracranial pressure (ICP), temperature, and partial pressure of oxygen (pO2)]. It consists of a single unit intended to be used with an invasive access device(s) [e.g., arterial blood pressure catheter, intracerebral sensor catheter] (not included) which signals the monitor via connected cables. It may be a portable device that can be attached to the patient with a strap and may include alarms designed to alert clinical staff. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1afae864-a962-4cad-938f-98324dec11e1
Public Version Date: May 06, 2020
Public Version Number: 3
DI Record Publish Date: August 18, 2016

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: +4992523590
Email: hospitalcare@raumedic.com

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

FDA TOOLS & RESOURCES