AccessGUDID - DEVICE: Scott Medical Products (00819601020542)

GUDID

Device Identifier (DI) Information

Brand Name: Scott Medical Products
Version or Model: Calibration Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z03NI748BDC007
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601020542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: 5% CO2, 21% O2, BAL. N2 with Filter Line; Cylinder: BD; Valve: Aerosol; 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?
35933	Multiple blood gas analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Liter
Pressure: 144 Pound per Square Inch

Device Record Status

Public Device Record Key: 5afb3493-db21-4e74-9f56-9fa4426f0699
Public Version Date: September 23, 2019
Public Version Number: 1
DI Record Publish Date: September 14, 2019