FDA.reportPublic FDA data

Scott Medical Products

Primary DI
00819601020313
Brand
Scott Medical Products
Company
AIRGAS USA LLC
Model
Pulmonary Function Gas
Catalog number
Z04NI68580A00JC
Device description
Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: BL; Valve: CGA 500; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.
Published
2019-07-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXKGas, Calibration (Specified Concentration)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819601020313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819601020313008196010203138196010203130819601020313

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Pressure2000Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius52 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-233-4334customerservice@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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819601021938Scott Medical ProductsCalibration GasZ03OX508SDC0002020-05-23
00819601025103Scott Medical ProductsAnesthesia Calibration GasZ04OX33KSD00002023-03-06
00819601024991Scott Medical ProductsAnesthesia Calibration GasZ02OX86MUD00002023-02-24
00819601025004Scott Medical ProductsAnesthesia Calibration GasZ03OX17MUD00002023-02-24
00819601025011Scott Medical ProductsAnesthesia Calibration GasZ03OX20MUD00012023-02-24
00819601025028Scott Medical ProductsAnesthesia Calibration GasZ03OX11MUD00012023-02-24
00819601025035Scott Medical ProductsAnesthesia Calibration GasZ03OX56MUD00002023-02-24
00819601025042Scott Medical ProductsCalibration GasZ02NI854SD00002023-02-24
00819601025059Scott Medical ProductsCalibration GasZ02NI804SD00002023-02-24
00819601025066Scott Medical ProductsCalibration GasZ03NI15415A00002023-02-24
00819601025073Scott Medical ProductsAnesthesia Calibration GasZ04NI70M15A00002023-02-25
00819601025080Scott Medical ProductsCalibration GasZ02NI83415A00012023-02-25
00819601025097Scott Medical ProductsCalibration GasZ02NI99415A00002023-02-25
00819601024960Bionostic, Inc.Calibration GasZ03NI85430000012023-02-17
00819601024977Bionostic, Inc.Calibration GasZ03NI82430000012023-02-17
00819601024984Bionostic, Inc.Calibration GasZ03NI874300Z2352023-02-17
00819601024632Scott Medical ProductsCalibration GasZ02NI978200C0002023-02-11
00819601024649Scott Medical ProductsAnesthesia Calibration GasZ03OX61MUD00012023-02-11
00819601024656Scott Medical ProductsAnesthesia Calibration GasZ03OX69MUD00042023-02-11
00819601024663Scott Medical ProductsAnesthesia Calibration GasZ02AI97MUD00012023-02-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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