AccessGUDID - DEVICE: Spacelabs Healthcare (10841522120336)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: VAPORIZER
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13000503
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522120336
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: VAP NO LABELS HALSELECTATEC KEY-FILL

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?
36891	Halothane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent halothane (also known as fluorothane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAD	VAPORIZER, ANESTHESIA, NON-HEATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942799	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 Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3856fbd4-58cc-4d5a-a53d-ec07a3b80b23
Public Version Date: December 16, 2022
Public Version Number: 5
DI Record Publish Date: December 29, 2016