FDA.report

Scott Medical Prodcuts

Primary DI
00819601020580
Brand
Scott Medical Prodcuts
Company
AIRGAS USA LLC
Model
Pulmonary Function Gas
Catalog number
Z04NI685EDC003
Device description
Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: ED; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
Published
2019-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications

CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10819601020587PackageGS12In Commercial Distribution
00819601020580PrimaryGS10

GMDN Terms

TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Device Sizes

TypeValueUnit
Pressure2200Pound per Square Inch
Total Volume560Liter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius52 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18002334334customerservice.healthcare@airliquide.com

Regulatory Flags

DUNS number
831996595
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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