AccessGUDID - DEVICE: Scott Medical Products (00819601020412)

GUDID

Device Identifier (DI) Information

Brand Name: Scott Medical Products
Version or Model: Pulmonary Function Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z04NI685EA0033
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601020412
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment 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?
35467	Carbon monoxide breath analyser	An electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere.	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: 620 Liter
Pressure: 2000 Pound per Square Inch

Device Record Status

Public Device Record Key: 403a2366-3bed-45ca-b81f-ad440511fb19
Public Version Date: August 27, 2019
Public Version Number: 1
DI Record Publish Date: August 19, 2019