AccessGUDID - DEVICE: Micro Medical (54250892980138)

GUDID

Device Identifier (DI) Information

Brand Name: Micro Medical
Version or Model: 36-RPM01-STK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 36-RPM01-STK
Company Name: CAREFUSION U.K. 232 LIMITED

Primary DI Number: 54250892980138
Issuing Agency: GS1
Commercial Distribution End Date: May 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 291555621 *Terms of Use

Device Description: MicroRPM

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?
31318	Airway pressure monitor, powered	A mains electricity (AC-powered) device designed to continuously measure and display the pressure values, positive and/or negative, in the upper airway (e.g., the maximal averaged inspiratory and expiratory static mouth pressure, and/or negative pressure generated by the patient during inspiration), typically in the assessment of patients with compromised pulmonary function and to determine the appropriateness of discontinuing mechanical ventilation. It typically includes a pressure indicator and a built-in alarm to signal pressure levels that exceed specific limits. It may contain batteries for independent operation when line-power is not available.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f12e050d-a6d0-4175-ab8a-f81e2dbe5482
Public Version Date: May 22, 2019
Public Version Number: 3
DI Record Publish Date: August 04, 2016