AccessGUDID - DEVICE: Spacelabs Healthcare (10841522118487)

GUDID

Device Identifier (DI) Information

Brand Name: Spacelabs Healthcare
Version or Model: DATUM
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13012108
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522118487
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: DATUM+ ISO TEC K/F - TAEMA (VD318600)

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?
36890	Isoflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent isoflurane 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 Temperature: between -20 and 50 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: 8e60955d-b1bf-4547-b75e-91eb223220dd
Public Version Date: July 12, 2019
Public Version Number: 5
DI Record Publish Date: December 29, 2016