AccessGUDID - DEVICE: Spacelabs Healthcare (10841522109836)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: 6500V; 8500V
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10110090
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522109836
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: PATIENT FLOW SENSOR - SINGLE UNIT

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?
36849	Breathing circuit gas-flow sensor, reusable	A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	VENTILATOR, CONTINUOUS, FACILITY USE

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: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba9c1c48-4dec-48b2-9036-9e010d1d5e90
Public Version Date: May 01, 2020
Public Version Number: 6
DI Record Publish Date: October 10, 2016