AccessGUDID - DEVICE: Scott Medical Products (00819601021983)

GUDID

Device Identifier (DI) Information

Brand Name: Scott Medical Products
Version or Model: Anesthesia Calibration Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z02NI97MUD0004
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601021983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: 3% SEVOFLURANE, BAL. N2; Cylinder: UD; Valve: CGA 165; For calibration of medical analyzers in accordance with manufacturer's instructions.

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):	No
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?
36892	Ether anaesthesia vaporizer	A device used to vaporize the anaesthetic agent ether 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, but some types may be used as stand-alone devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXK	Gas, Calibration (Specified Concentration)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: less than 52 Degrees Celsius
Handling Environment Temperature: more than 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Pressure: 24 Pound per Square Inch
Total Volume: 36 Liter

Device Record Status

Public Device Record Key: c6d00203-9605-416b-b662-975d8812f5c8
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 2020