AccessGUDID - DEVICE: IntelliVue NMT Hand-Adapter (30884838085153)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliVue NMT Hand-Adapter
Version or Model: IntelliVue NMT Hand-Adapter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803199211
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 30884838085153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: IntelliVue NMT Hand Adapter for use with IntelliVue NMT Patient Cable 989803174581 and IntelliVue Neuro Muscular Transmission Module 865383. Adapter is reusable. 1 Sales Unit = 10 each

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?
43266	Sensor holder, reusable	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position. This device will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body during computer assisted surgery (CAS), another device, or a suitable place in the vicinity of use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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 -40 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ac5be08-529c-4b50-b776-395863b86c22
Public Version Date: May 05, 2023
Public Version Number: 6
DI Record Publish Date: August 21, 2019