AccessGUDID - DEVICE: ReDS Pro System (07290110070151)

GUDID

Device Identifier (DI) Information

Brand Name: ReDS Pro System
Version or Model: V2.7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAK0012
Company Name: SENSIBLE MEDICAL INNOVATIONS LTD

Primary DI Number: 07290110070151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532269045 *Terms of Use

Device Description: Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Pro System)

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):	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?
35242	Whole-body plethysmograph	A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSB	Plethysmograph, Impedance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180479	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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4b511ad8-76d1-4ad1-be01-3d26fb067ad1
Public Version Date: June 19, 2019
Public Version Number: 1
DI Record Publish Date: June 11, 2019