AccessGUDID - DEVICE: Blease (10841522102967)

GUDID

Device Identifier (DI) Information

Brand Name: Blease
Version or Model: SIRIUS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N/A
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522102967
Issuing Agency: GS1
Commercial Distribution End Date: July 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: FIELD UPGRADE ABSORBER LOCK

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:	Yes
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?
47769	Anaesthesia unit, mobile	A stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSZ	Gas-machine, anesthesia

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2e021d0-4d5c-44c4-b47a-fe20d7339159
Public Version Date: August 17, 2018
Public Version Number: 1
DI Record Publish Date: July 17, 2018